Tobacco Use Disorder Clinical Trial
Official title:
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking 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 on the effectiveness of nicotine replacement therapy. This may lead to improved 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, such as the taste, sight, and smell of smoke. Tailoring treatment
to the separate needs of subgroups, such as men and women, may produce better outcomes. The
purpose of this study is to assess the influence of gender on the effectiveness of
transdermal nicotine treatment in a group of male and female smokers.
Participants in this double-blind, dose-comparison study will complete separate sessions in
a random order.
Each session will last approximately 6.5 hours and will correspond to a specific transdermal
patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required
before each session. Sessions will occur at least 48 hours apart to avoid carryover.
Cognitive, behavioral, subjective, and physiological measures will occur during study
visits. Specifically, the NRT dose response to tobacco suppression and cigarette blunting
effects will be compared in women and men.
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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