Trial Outcomes & Findings for Treatment of Smoking Lapses and Relapses (NCT NCT01807871)
NCT ID: NCT01807871
Last Updated: 2017-10-13
Results Overview
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
COMPLETED
PHASE4
701 participants
4 months after the quit date
2017-10-13
Participant Flow
Recruitment between April 2013 and July 2015
Participant milestones
| Measure |
Nicotine Patch, Experimental Use
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
|---|---|---|
|
Overall Study
STARTED
|
356
|
345
|
|
Overall Study
COMPLETED
|
178
|
127
|
|
Overall Study
NOT COMPLETED
|
178
|
218
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Smoking Lapses and Relapses
Baseline characteristics by cohort
| Measure |
Nicotine Patch, Experimental Use
n=356 Participants
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
n=345 Participants
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
Total
n=701 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11 • n=5 Participants
|
45 years
STANDARD_DEVIATION 12 • n=7 Participants
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
170 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
128 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
45 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
356 participants
n=5 Participants
|
345 participants
n=7 Participants
|
701 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 months after the quit datePopulation: Participants who lapsed while using the nicotine patch
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
Outcome measures
| Measure |
Nicotine Patch, Experimental Use
n=178 Participants
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
n=127 Participants
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
|---|---|---|
|
Point-prevalent Abstinence at 4 Months
|
90 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 4 months after the quit datePopulation: Because the results for the primary outcome were negative, this outcome was not analyzed (i.e., there was no effect to mediate).
To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: All randomized participants
To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.
Outcome measures
| Measure |
Nicotine Patch, Experimental Use
n=356 Participants
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
n=345 Participants
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
|---|---|---|
|
Adverse Drug Effects
|
37 Participants
|
27 Participants
|
Adverse Events
Nicotine Patch, Experimental Use
Nicotine Patch, Labeled Use
Serious adverse events
| Measure |
Nicotine Patch, Experimental Use
n=356 participants at risk
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
n=345 participants at risk
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/356 • 12 weeks
|
0.29%
1/345 • 12 weeks
|
|
Gastrointestinal disorders
Intestinal problems
|
0.28%
1/356 • 12 weeks
|
0.29%
1/345 • 12 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.28%
1/356 • 12 weeks
|
0.00%
0/345 • 12 weeks
|
|
Endocrine disorders
Pancreas problems
|
0.00%
0/356 • 12 weeks
|
0.58%
2/345 • 12 weeks
|
|
General disorders
Hospitalization
|
0.56%
2/356 • 12 weeks
|
0.00%
0/345 • 12 weeks
|
Other adverse events
| Measure |
Nicotine Patch, Experimental Use
n=356 participants at risk
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
|
Nicotine Patch, Labeled Use
n=345 participants at risk
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
22.2%
79/356 • 12 weeks
|
22.6%
78/345 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
34.3%
122/356 • 12 weeks
|
34.8%
120/345 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
9.3%
33/356 • 12 weeks
|
9.0%
31/345 • 12 weeks
|
|
Nervous system disorders
Headache
|
12.4%
44/356 • 12 weeks
|
10.7%
37/345 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.8%
35/356 • 12 weeks
|
8.7%
30/345 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place