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The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and nicotine-free cigarette compared to 21 mg nicotine patch only and nicotine-free cigarette only on abstinence and withdrawal symptoms. The study will determine if adding nicotine replacement medication to the nicotine-free cigarettes will augment treatment compared to nicotine patch only or to nicotine-free cigarettes only.
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and nicotine-free cigarette compared to the nicotine-free cigarette alone or 21 mg nicotine patch alone on abstinence and withdrawal.
The following primary hypothesis will be tested:
-1)Abstinence rates will be highest and the time to relapse will be the longest in the nicotine-free cigarettes plus nicotine patch condition compared to nicotine patch or nicotine-free cigarettes alone.
Other hypotheses include:
- 1)Greater positive subjective responses to cigarettes will be observed with nicotine-free cigarettes plus patch vs. nicotine-free cigarette;
- 2)Less drop-outs will be observed in the nicotine-free plus patch vs the other two conditions;
- 3)Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette condition and the nicotine patch alone condition, and least withdrawal and negative affect with the nicotine-free cigarette plus nicotine patch condition; and
- 4)Less compensatory smoking will be observed in the nicotine-free plus patch condition compared to nicotine-free cigarette alone condition.
Cigarette smokers will be randomized to:
1)denicotinized cigarettes (which provide sensory behavioral aspects of smoking but with no nicotine) plus nicotine patch for 6 weeks; -2)nicotine patch for 6 weeks; or - 3)denicotinized cigarettes alone.
Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 12, 16, 24 and 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, withdrawal symptoms and craving and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Nicotine Patch, Nicotine Free Cigarettes, Nicotine Free Cigarette Plus Nicotine Patch
University of MN's Tobacco Use Research Center
National Institute on Drug Abuse (NIDA)
Published on BioPortfolio: 2014-08-27T03:16:34-0400
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