Trial Outcomes & Findings for Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS) (NCT NCT03611881)
NCT ID: NCT03611881
Last Updated: 2024-10-28
Results Overview
Number of participants that self-reported no cigarette smoking in the past 7 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
642 participants
Primary outcome timeframe
6 Months after enrollment
Results posted on
2024-10-28
Participant Flow
Participant milestones
| Measure |
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
80
|
79
|
79
|
81
|
81
|
78
|
|
Overall Study
COMPLETED
|
82
|
82
|
80
|
79
|
79
|
81
|
81
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
Baseline characteristics by cohort
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Total
n=642 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
45 Participants
n=30 Participants
|
49 Participants
n=3 Participants
|
48 Participants
n=6 Participants
|
377 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
36 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
265 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
51 Participants
n=30 Participants
|
50 Participants
n=3 Participants
|
35 Participants
n=6 Participants
|
358 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
43 Participants
n=6 Participants
|
284 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
47 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
70 Participants
n=31 Participants
|
69 Participants
n=30 Participants
|
72 Participants
n=3 Participants
|
67 Participants
n=6 Participants
|
571 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
67 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
70 Participants
n=31 Participants
|
68 Participants
n=30 Participants
|
70 Participants
n=3 Participants
|
65 Participants
n=6 Participants
|
540 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
|
Language
English
|
78 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
77 Participants
n=30 Participants
|
78 Participants
n=3 Participants
|
75 Participants
n=6 Participants
|
621 Participants
n=114 Participants
|
|
Language
Spanish
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 6 Months after enrollmentNumber of participants that self-reported no cigarette smoking in the past 7 days
Outcome measures
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Self-reported Past 7-day Smoking Abstinence
|
12 Participants
|
10 Participants
|
12 Participants
|
15 Participants
|
6 Participants
|
10 Participants
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 months after enrollmentNumber of participants that self-reported no cigarettes smoked in the past 7 days
Outcome measures
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Self-Reported Past 7-day Smoking Abstinence
|
6 Participants
|
11 Participants
|
10 Participants
|
14 Participants
|
8 Participants
|
14 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsProportion of participants who reduced the number of cigarettes smoked per day in half
Outcome measures
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
|
21 Participants
|
24 Participants
|
31 Participants
|
23 Participants
|
21 Participants
|
27 Participants
|
29 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 monthsProportion of participants who reduced the number of cigarettes smoked per day in half
Outcome measures
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
|
21 Participants
|
23 Participants
|
23 Participants
|
26 Participants
|
19 Participants
|
21 Participants
|
26 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 3 monthsIntentional attempt to quit smoking cigarettes that lasts for \>=24 hours
Outcome measures
| Measure |
Short, Short, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Long, Present
n=82 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Short, Present
n=80 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Long, Long, Present
n=79 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
|
Short, Short, Absent
n=79 Participants
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Short, Long, Absent
n=81 Participants
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Short, Absent
n=81 Participants
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
Long, Long, Absent
n=78 Participants
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients Who Make an Intentional Attempt to Quit Smoking
|
37 Participants
|
40 Participants
|
33 Participants
|
44 Participants
|
36 Participants
|
38 Participants
|
35 Participants
|
29 Participants
|
Adverse Events
Short, Short, Present
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short, Long, Present
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long, Short, Present
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long, Long, Present
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short, Short, Absent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short, Long, Absent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long, Short, Absent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long, Long, Absent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elyse Park, PhD, Professor of Psychiatry and Medicine, Harvard Medical School
Massachusetts General Hospital
Phone: 617.724.6836
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place