Trial Outcomes & Findings for Cessation Screening Project (NCT NCT04188873)
NCT ID: NCT04188873
Last Updated: 2026-06-17
Results Overview
Participants will be asked to report on any smoking in the last seven days at a follow-up phone interview scheduled to occur 12-months post-target quit day (post-TQD). Those claiming complete abstinence (not even a puff from a cigarette) in the last seven days at this follow-up interview will be asked to provide a saliva sample for biochemical verification of self-reported abstinence via cotinine testing. Participants who report abstinence in the last 7 days at this visit but have a cotinine level \>10ng/mL or who do not have provide a cotinine result will be considered to be smoking. Reported here as participant count of those considered Smoking and Abstinent per condition.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
538 participants
Primary outcome timeframe
12 months post-target quit day (TQD)
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
12-week Varenicline With Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Combination Nicotine Replacement (C-NRT) With Minimal Counseling
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination Nicotine Replacement Therapy (NRT): 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
42
|
33
|
31
|
34
|
29
|
35
|
36
|
27
|
37
|
35
|
31
|
30
|
37
|
28
|
|
Overall Study
COMPLETED
|
28
|
20
|
35
|
21
|
20
|
20
|
21
|
24
|
23
|
17
|
30
|
25
|
24
|
24
|
25
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
7
|
12
|
11
|
14
|
8
|
11
|
13
|
10
|
7
|
10
|
7
|
6
|
12
|
11
|
Reasons for withdrawal
| Measure |
12-week Varenicline With Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Combination Nicotine Replacement (C-NRT) With Minimal Counseling
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination Nicotine Replacement Therapy (NRT): 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
12
|
3
|
7
|
9
|
12
|
4
|
6
|
12
|
8
|
4
|
7
|
6
|
4
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
4
|
5
|
2
|
2
|
4
|
5
|
1
|
2
|
3
|
3
|
1
|
2
|
2
|
4
|
Baseline Characteristics
Cessation Screening Project
Baseline characteristics by cohort
| Measure |
12-week Varenicline With Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
n=42 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
n=29 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With Minimal Counseling
n=27 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
n=35 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
n=30 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
n=36 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.75676 years
STANDARD_DEVIATION 13.03927 • n=9 Participants
|
51.36111 years
STANDARD_DEVIATION 12.66526 • n=27 Participants
|
50.7381 years
STANDARD_DEVIATION 14.92103 • n=267 Participants
|
50.84848 years
STANDARD_DEVIATION 12.3266 • n=265 Participants
|
54.19355 years
STANDARD_DEVIATION 10.30669 • n=568 Participants
|
54.05882 years
STANDARD_DEVIATION 11.84992 • n=22 Participants
|
56.58621 years
STANDARD_DEVIATION 10.83486 • n=23 Participants
|
53.68571 years
STANDARD_DEVIATION 12.43991 • n=22 Participants
|
51.81481 years
STANDARD_DEVIATION 10.37763 • n=178 Participants
|
55.02703 years
STANDARD_DEVIATION 11.71771 • n=116 Participants
|
52.02857 years
STANDARD_DEVIATION 12.64559 • n=2 Participants
|
50.35484 years
STANDARD_DEVIATION 11.57742 • n=4 Participants
|
57.0000 years
STANDARD_DEVIATION 10.7222 • n=190 Participants
|
52.02703 years
STANDARD_DEVIATION 12.90884 • n=19 Participants
|
51.19444 years
STANDARD_DEVIATION 12.34462 • n=18 Participants
|
52.32143 years
STANDARD_DEVIATION 12.18394 • n=18 Participants
|
52.66543 years
STANDARD_DEVIATION 12.21455 • n=14 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
20 Participants
n=22 Participants
|
17 Participants
n=23 Participants
|
20 Participants
n=22 Participants
|
13 Participants
n=178 Participants
|
21 Participants
n=116 Participants
|
17 Participants
n=2 Participants
|
22 Participants
n=4 Participants
|
14 Participants
n=190 Participants
|
20 Participants
n=19 Participants
|
23 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
304 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
15 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
12 Participants
n=23 Participants
|
15 Participants
n=22 Participants
|
14 Participants
n=178 Participants
|
16 Participants
n=116 Participants
|
18 Participants
n=2 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=190 Participants
|
17 Participants
n=19 Participants
|
13 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
234 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
17 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=9 Participants
|
36 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
29 Participants
n=265 Participants
|
30 Participants
n=568 Participants
|
34 Participants
n=22 Participants
|
29 Participants
n=23 Participants
|
34 Participants
n=22 Participants
|
27 Participants
n=178 Participants
|
37 Participants
n=116 Participants
|
34 Participants
n=2 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=190 Participants
|
35 Participants
n=19 Participants
|
35 Participants
n=18 Participants
|
27 Participants
n=18 Participants
|
520 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
19 Participants
n=265 Participants
|
13 Participants
n=568 Participants
|
17 Participants
n=22 Participants
|
12 Participants
n=23 Participants
|
17 Participants
n=22 Participants
|
11 Participants
n=178 Participants
|
12 Participants
n=116 Participants
|
19 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=190 Participants
|
17 Participants
n=19 Participants
|
15 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
239 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
15 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
16 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
21 Participants
n=116 Participants
|
15 Participants
n=2 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=190 Participants
|
17 Participants
n=19 Participants
|
20 Participants
n=18 Participants
|
14 Participants
n=18 Participants
|
260 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
18 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
13 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=9 Participants
|
36 participants
n=27 Participants
|
42 participants
n=267 Participants
|
33 participants
n=265 Participants
|
31 participants
n=568 Participants
|
34 participants
n=22 Participants
|
29 participants
n=23 Participants
|
35 participants
n=22 Participants
|
27 participants
n=178 Participants
|
37 participants
n=116 Participants
|
35 participants
n=2 Participants
|
31 participants
n=4 Participants
|
30 participants
n=190 Participants
|
37 participants
n=19 Participants
|
36 participants
n=18 Participants
|
28 participants
n=18 Participants
|
538 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 12 months post-target quit day (TQD)Participants will be asked to report on any smoking in the last seven days at a follow-up phone interview scheduled to occur 12-months post-target quit day (post-TQD). Those claiming complete abstinence (not even a puff from a cigarette) in the last seven days at this follow-up interview will be asked to provide a saliva sample for biochemical verification of self-reported abstinence via cotinine testing. Participants who report abstinence in the last 7 days at this visit but have a cotinine level \>10ng/mL or who do not have provide a cotinine result will be considered to be smoking. Reported here as participant count of those considered Smoking and Abstinent per condition.
Outcome measures
| Measure |
12-week Varenicline With Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
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12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week Varenicline With Minimal Counseling
n=42 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
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12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
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24-week Varenicline With Intensive Counseling
n=29 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
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24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
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12-week C-NRT With Minimal Counseling
n=27 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
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12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week C-NRT With Minimal Counseling
n=35 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
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12-week C-NRT With Intensive Counseling
n=30 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
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12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
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24-week C-NRT With Intensive Counseling
n=36 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
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24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Intent-to-treat Biochemically Verified 7-day Point Prevalence Abstinence
Smoking
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31 Participants
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33 Participants
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33 Participants
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30 Participants
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26 Participants
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29 Participants
|
27 Participants
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27 Participants
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25 Participants
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31 Participants
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30 Participants
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26 Participants
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24 Participants
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30 Participants
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29 Participants
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24 Participants
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Intent-to-treat Biochemically Verified 7-day Point Prevalence Abstinence
Abstinent
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6 Participants
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3 Participants
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9 Participants
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3 Participants
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5 Participants
|
5 Participants
|
2 Participants
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8 Participants
|
2 Participants
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6 Participants
|
5 Participants
|
5 Participants
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6 Participants
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7 Participants
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7 Participants
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4 Participants
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SECONDARY outcome
Timeframe: 12 months post-target quit day (TQD)The per participant implementation cost (minus research-related costs) for each intervention will be computed from a payer perspective. For each intervention, the total implementation cost will be divided by the number of participants randomized to the intervention to determine the implementation cost per participant in US dollars.
Outcome measures
| Measure |
12-week Varenicline With Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
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12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week Varenicline With Minimal Counseling
n=42 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
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24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
n=29 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With Minimal Counseling
n=27 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
n=35 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
n=30 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
n=36 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Implementation Cost Per Participant
|
146.79 US Dollars per participant
Standard Deviation 56.28
|
174.75 US Dollars per participant
Standard Deviation 62.17
|
189.15 US Dollars per participant
Standard Deviation 136.47
|
182.62 US Dollars per participant
Standard Deviation 140.56
|
198.49 US Dollars per participant
Standard Deviation 96.82
|
220.34 US Dollars per participant
Standard Deviation 138.31
|
230.35 US Dollars per participant
Standard Deviation 134.70
|
221.57 US Dollars per participant
Standard Deviation 148.52
|
205.95 US Dollars per participant
Standard Deviation 153.23
|
250.72 US Dollars per participant
Standard Deviation 201.76
|
240.55 US Dollars per participant
Standard Deviation 191.56
|
333.29 US Dollars per participant
Standard Deviation 277.99
|
268.40 US Dollars per participant
Standard Deviation 158.41
|
252.39 US Dollars per participant
Standard Deviation 164.08
|
287.43 US Dollars per participant
Standard Deviation 191.27
|
353.04 US Dollars per participant
Standard Deviation 261.76
|
SECONDARY outcome
Timeframe: 12 months post-target quit day (TQD)The cost per quit will be determined by computing total implementation cost (minus research-related costs) from a payer perspective and dividing by the number of participants who quit smoking, as verified by 7-day point prevalence abstinence at 12 months post-TQD. Cost per quit will be reported as US dollars per individual who quit smoking.
Outcome measures
| Measure |
12-week Varenicline With Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
n=42 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
n=29 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 Participants
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With Minimal Counseling
n=27 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
n=35 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
n=30 Participants
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
n=36 Participants
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 Participants
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cost Per Quit
|
880.75 US Dollars per quit
Interval 470.18 to 2121.32
|
1747.46 US Dollars per quit
Interval 816.36 to
Upper limit of 95% CI not reached due to the denominator of the cost-effectiveness ratio approaching zero at the 2.5th percentile, resulting in an unbounded (infinite) upper confidence limit.
|
735.59 US Dollars per quit
Interval 440.72 to 1754.69
|
1826.20 US Dollars per quit
Interval 891.19 to
Upper limit of 95% CI not reached due to the denominator of the cost-effectiveness ratio approaching zero at the 2.5th percentile, resulting in an unbounded (infinite) upper confidence limit.
|
1389.42 US Dollars per quit
Interval 689.36 to 6063.68
|
1233.91 US Dollars per quit
Interval 665.42 to 5092.87
|
2648.98 US Dollars per quit
Interval 1028.39 to
Upper limit of 95% CI not reached due to the denominator of the cost-effectiveness ratio approaching zero at the 2.5th percentile, resulting in an unbounded (infinite) upper confidence limit.
|
1144.78 US Dollars per quit
Interval 633.82 to 3816.91
|
2780.32 US Dollars per quit
Interval 1153.66 to
Upper limit of 95% CI not reached due to the denominator of the cost-effectiveness ratio approaching zero at the 2.5th percentile, resulting in an unbounded (infinite) upper confidence limit.
|
1546.10 US Dollars per quit
Interval 827.09 to 4890.17
|
1683.82 US Dollars per quit
Interval 848.03 to 7538.65
|
2066.43 US Dollars per quit
Interval 1201.63 to 6930.3
|
1342.01 US Dollars per quit
Interval 731.88 to 4293.32
|
1334.04 US Dollars per quit
Interval 770.42 to 3522.72
|
1478.19 US Dollars per quit
Interval 915.57 to 4380.89
|
2471.25 US Dollars per quit
Interval 1283.27 to 11024.3
|
Adverse Events
12-week Varenicline With Minimal Counseling
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
24-week Varenicline With Minimal Counseling
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
12-week Varenicline With Intensive Counseling
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
24-week Varenicline With Intensive Counseling
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
12-week C-NRT With Minimal Counseling
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Serious events: 5 serious events
Other events: 0 other events
Deaths: 2 deaths
24-week C-NRT With Minimal Counseling
Serious events: 6 serious events
Other events: 2 other events
Deaths: 1 deaths
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
12-week C-NRT With Intensive Counseling
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Serious events: 8 serious events
Other events: 4 other events
Deaths: 1 deaths
24-week C-NRT With Intensive Counseling
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
Serious events: 9 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
12-week Varenicline With Minimal Counseling
n=37 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
n=42 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
n=29 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With Minimal Counseling
n=27 participants at risk
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
n=35 participants at risk
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
n=30 participants at risk
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
n=36 participants at risk
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Eye disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Gastrointestinal disorders
Hospitalization
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.8%
1/36 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
General disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
10.8%
4/37 • Number of events 4 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
8.6%
3/35 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Infections and infestations
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
14.3%
5/35 • Number of events 5 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Injury, poisoning and procedural complications
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
6.5%
2/31 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Nervous system disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Renal and urinary disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
9.7%
3/31 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
21.6%
8/37 • Number of events 8 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
5.6%
2/36 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Surgical and medical procedures
Hospitalization
|
13.5%
5/37 • Number of events 5 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
9.7%
3/31 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Cardiac disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
21.4%
6/28 • Number of events 6 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Vascular disorders
Hospitalization
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
Other adverse events
| Measure |
12-week Varenicline With Minimal Counseling
n=37 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Varenicline: 12 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=36 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With Minimal Counseling
n=42 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Varenicline: 24 weeks of varenicline
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Minimal Counseling
n=33 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week Varenicline With Intensive Counseling
n=31 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Varenicline: 12 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
12-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=34 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Standard Duration Varenicline: 16 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With Intensive Counseling
n=29 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Varenicline: 24 weeks of varenicline
Intensive Counseling: 4 phone or video counseling sessions
|
24-week Varenicline With 4-Week Preparation Varenicline and Intensive Counseling
n=35 participants at risk
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Varenicline and Extended Duration Varenicline: 28 weeks of varenicline starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With Minimal Counseling
n=27 participants at risk
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=37 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With Minimal Counseling
n=35 participants at risk
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Minimal Counseling: 2 brief phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Minimal Counseling
n=31 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Minimal Counseling: 2 brief phone or video counseling sessions
|
12-week C-NRT With Intensive Counseling
n=30 participants at risk
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Standard Duration Combination NRT: 12 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
12-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=37 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Standard Duration Combination NRT: 16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With Intensive Counseling
n=36 participants at risk
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Extended Duration Combination NRT: 24 weeks of nicotine patch + nicotine mini-lozenge
Intensive Counseling: 4 phone or video counseling sessions
|
24-week C-NRT With 4-Week Preparation C-NRT and Intensive Counseling
n=28 participants at risk
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke \>10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Preparation Combination NRT and Extended Duration Combination NRT: 28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
Intensive Counseling: 4 phone or video counseling sessions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Gastrointestinal disorders
Gas, severe
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Cardiac disorders
irregular heartbeat
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Skin and subcutaneous tissue disorders
itching or hives
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Gastrointestinal disorders
constipation, severe
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Gastrointestinal disorders
mouth or throat swelling, severe
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Respiratory, thoracic and mediastinal disorders
chest tightness, severe
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Respiratory, thoracic and mediastinal disorders
trouple breathing
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
10.8%
4/37 • Number of events 4 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Nervous system disorders
insomnia
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
8.6%
3/35 • Number of events 3 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Psychiatric disorders
mood
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Skin and subcutaneous tissue disorders
skinrash
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Nervous system disorders
dreams
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/28 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
|
Psychiatric disorders
suicidal
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/42 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/33 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/34 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/29 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/27 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/35 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/31 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/30 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/37 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
0.00%
0/36 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected for 26 weeks, which coincides with the duration of intervention treatment
All adverse event reporting is based on participant self-report.
|
Additional Information
Associate Director of Research
University of Wisconsin Center for Tobacco Research and Intervention
Phone: 608-265-5472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place