Treatment of Smoking Lapses and Relapses
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|ClinicalTrials.gov Identifier: NCT01807871|
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 28, 2017
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: nicotine patch, experimental use Drug: nicotine patch, labeled use||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||701 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Smoking Lapses and Relapses|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: 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.
Drug: 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.
Active Comparator: 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.
Drug: 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 [ Time Frame: 4 months after the quit date ]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".
- Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence [ Time Frame: 4 months after the quit date ]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.
- Adverse Drug Effects [ Time Frame: Up to 12 weeks ]To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807871
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||John R Hughes, MD||University of Vermont|