Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

Not Applicable

Completed

Conditions: Drug Addiction
Smoking Cessation

Interventions: Drug: Nicotine transdermal system
Other: Nicotine containing cigarette
Other: Placebo cigarette

Registration Number: NCT00390559

Lead Sponsor: Virginia Commonwealth University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ActiveP/ActiveC	Nicotine transdermal system	21 mg patch/Nicotine-containing cigarette
ActiveP/ActiveC	Nicotine containing cigarette	21 mg patch/Nicotine-containing cigarette
PlaceboP/ActiveC	Nicotine transdermal system	0 mg patch/nicotine-containing cigarette
PlaceboP/ActiveC	Nicotine containing cigarette	0 mg patch/nicotine-containing cigarette
Active P/PlaceboC	Nicotine transdermal system	21 mg patch/no nicotine cigarette
Active P/PlaceboC	Placebo cigarette	21 mg patch/no nicotine cigarette
PlaceboP/PlaceboC	Nicotine transdermal system	0 mg patch/no nicotine cigarette
PlaceboP/PlaceboC	Placebo cigarette	0 mg patch/no nicotine cigarette

Primary Outcome Measures

Name	Time	Method
Subjective Effects	6 hours	The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").

Secondary Outcome Measures