Trial Outcomes & Findings for Evaluation of Learning-Theory-Based Smoking Cessation Strategies (NCT NCT01368653)
NCT ID: NCT01368653
Last Updated: 2022-04-27
Results Overview
7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
4 weeks
Results posted on
2022-04-27
Participant Flow
Recruitment occurred between June 12, 2012 and May 24, 2013 through community-wide recruitment including direct mail, flyers, and radio advertising.
Randomization was in 2 phases; 1: participants who met inclusion/exclusion criteria were randomized to either standard treatment or standard treatment plus practice quitting; in phase 2, smokers who smoked between weeks 3 and 4 post-quit were randomly assigned to either receive advice only, or advice plus very low nicotine cigarettes.
Participant milestones
| Measure |
Standard Treatment
In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
Completed 4-week Follow-up
|
44
|
37
|
|
Overall Study
Smoked in Past 7 Days at 4-weeks
|
29
|
20
|
|
Overall Study
Randomized to Phase 2
|
21
|
19
|
|
Overall Study
Randomized to VLNC in Phase 2
|
11
|
9
|
|
Overall Study
Randomized to Advice Only in Phase 2
|
10
|
10
|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Learning-Theory-Based Smoking Cessation Strategies
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=47 Participants
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 Participants
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Total
n=93 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
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
47.13 years
STANDARD_DEVIATION 14.27 • n=99 Participants
|
48.41 years
STANDARD_DEVIATION 10.36 • n=107 Participants
|
47.76 years
STANDARD_DEVIATION 12.44 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
46 participants
n=107 Participants
|
93 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
Outcome measures
| Measure |
Standard Treatment
n=47 Participants
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 Participants
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
4-week Abstinence
Abstinent (no smoking reported in past 7 days)
|
15 participants
|
17 participants
|
—
|
—
|
|
4-week Abstinence
Smoking (any cigarettes in past 7 days)
|
29 participants
|
20 participants
|
—
|
—
|
|
4-week Abstinence
Lost to 4-week follow-up
|
3 participants
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 weeksThis captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.
Outcome measures
| Measure |
Standard Treatment
n=47 Participants
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 Participants
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
n=20 Participants
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
n=20 Participants
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
10-week Abstinence
Abstinent (no smoking past 7 days) CO-confirmed
|
5 participants
|
11 participants
|
2 participants
|
1 participants
|
|
10-week Abstinence
Smoking (any cigarettes in past 7 days)
|
36 participants
|
26 participants
|
17 participants
|
19 participants
|
|
10-week Abstinence
Lost to 10-week follow-up
|
6 participants
|
9 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 weeks pre-quitPopulation: Participants who quit for at least 1 day in the first 2 weeks after the target quit date.
Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident.
Outcome measures
| Measure |
Standard Treatment
n=37 Participants
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=37 Participants
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
|
4.39 units on a scale
Standard Error 0.14
|
3.70 units on a scale
Standard Error 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 weeksThis outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.
Outcome measures
| Measure |
Standard Treatment
n=47 Participants
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 Participants
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
n=20 Participants
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
n=20 Participants
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
Prolonged Abstinence
Lost to 10-week follow-up
|
6 participants
|
9 participants
|
1 participants
|
0 participants
|
|
Prolonged Abstinence
Abstinent (no smoking 7 days in a row)
|
14 participants
|
20 participants
|
1 participants
|
6 participants
|
|
Prolonged Abstinence
Smoking (7 days in a row)
|
27 participants
|
17 participants
|
18 participants
|
14 participants
|
Adverse Events
Standard Treatment
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Standard Treatment+Practice Quitting
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Very Low Nicotine Cigarettes
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Advice and Encouragement Only
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Treatment
n=47 participants at risk
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 participants at risk
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
n=20 participants at risk
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
n=20 participants at risk
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
Infections and infestations
Tooth abscess
|
0.00%
0/47 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
2.2%
1/46 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Gastrointestinal disorders
Upper GI tract disorder
|
0.00%
0/47 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
2.2%
1/46 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Injury, poisoning and procedural complications
Broken toe
|
2.1%
1/47 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/46 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Gastrointestinal disorders
Chest pain
|
2.1%
1/47 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/46 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Musculoskeletal and connective tissue disorders
Leg and back pain
|
2.1%
1/47 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/46 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/47 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
2.2%
1/46 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
General disorders
Respiratory distress, diabetes, and dehydration
|
0.00%
0/47 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
2.2%
1/46 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
Other adverse events
| Measure |
Standard Treatment
n=47 participants at risk
In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
|
Standard Treatment+Practice Quitting
n=46 participants at risk
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
Very Low Nicotine Cigarettes
n=20 participants at risk
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
Advice and Encouragement Only
n=20 participants at risk
Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection, congestion, or illness
|
12.8%
6/47 • Number of events 7 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
15.2%
7/46 • Number of events 7 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
15.0%
3/20 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
20.0%
4/20 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
8/47 • Number of events 8 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
15.2%
7/46 • Number of events 7 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
20.0%
4/20 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
20.0%
4/20 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Psychiatric disorders
Sleep disturbance
|
10.6%
5/47 • Number of events 5 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
13.0%
6/46 • Number of events 6 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
20.0%
4/20 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
15.0%
3/20 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
10.6%
5/47 • Number of events 6 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
2.2%
1/46 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
General disorders
Headache
|
8.5%
4/47 • Number of events 5 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
6.5%
3/46 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
10.0%
2/20 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation, rash, or pain
|
10.6%
5/47 • Number of events 5 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
6.5%
3/46 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
5.0%
1/20 • Number of events 1 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
20.0%
4/20 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
General disorders
Dizziness or lightheadedness
|
8.5%
4/47 • Number of events 4 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
4.3%
2/46 • Number of events 2 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
10.0%
2/20 • Number of events 2 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
|
General disorders
Fatigue
|
6.4%
3/47 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
4.3%
2/46 • Number of events 3 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
0.00%
0/20 • All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
|
Additional Information
Danielle E. McCarthy, Ph.D.
Rutgers, The State University of New Jersey
Phone: 608-265-5949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place