Smoking Cessation Clinical Trial
Official title:
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.
Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments
are unsuccessful. Treatment studies have demonstrated that current smoking cessation
techniques are less effective for women. There is no clear explanation for this difference,
but it may involve a differential response to nicotine replacement treatments (NRTs) and/or
smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or
blunting the effects of smoking during a quit attempt. Women may also be more sensitive to
smoking-related stimuli, suc has the taste, sight, or smell of cigarette smoke. Tailoring
treatments to the separate needs of smoker subgroups , such as men and women, my produce
better cessation outcomes. The purpose of this study is to assess whether men and women
differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related
stimuli.
Participants in this double-blind, dose-comparison study will complete separate sessions in
random order.
Each session will last approximately 6.5 hours and will correspond to a transdermal patch
dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified
cigarette abstinence will be required before each session. Sessions will occur at least 48
hours apart to avoid carryover. At the beginning of each session a patch will be placed on
the participant's back and at 4, 5, and 6 hours after patch application the participant will
smoke a cigarette (all identifying marking on the cigarette will be covered for blinding
purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be
collected during study visits.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
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