Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Condition: Drug Addiction; Smoking Cessation
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): nicotine transdermal system; Nicotine transdermal system; Nicotine containing cigarette; Placebo cigarette
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 21 mg nicotine transdermal system; Placebo nicotine patch; Nicotine containing cigarette; Non nicotine containing cigarette
Other intervention name(s): Nicoderm CQ
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nicotine Replacement Therapy; Tobacco Smoking; Smoking stimuli; Gender