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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women

Conditions
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Drug Addiction, Smoking Cessation

Intervention / Treatment
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* Drug: nicotine transdermal system
* Drug: Nicotine transdermal system
* Other: Nicotine containing cigarette
* Other: Placebo cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include, but are not limited to: 18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks. Exclusion Criteria include, but are not limited to: History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActiveP/ActiveC<br>21 mg patch/Nicotine-containing cigarette | Drug: nicotine transdermal system<br>* 21 mg nicotine transdermal system<br>* Other names: Nicoderm CQ;Other: Nicotine containing cigarette<br>* Nicotine containing cigarette<br>|
| Experimental: PlaceboP/ActiveC<br>0 mg patch/nicotine-containing cigarette | Drug: Nicotine transdermal system<br>* Placebo nicotine patch<br>Other: Nicotine containing cigarette<br>* Nicotine containing cigarette<br>|
| Experimental: Active P/PlaceboC<br>21 mg patch/no nicotine cigarette | Drug: nicotine transdermal system<br>* 21 mg nicotine transdermal system<br>* Other names: Nicoderm CQ;Other: Placebo cigarette<br>* Non nicotine containing cigarette<br>|
| Experimental: PlaceboP/PlaceboC<br>0 mg patch/no nicotine cigarette | Drug: Nicotine transdermal system<br>* Placebo nicotine patch<br>Other: Placebo cigarette<br>* Non nicotine containing cigarette<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Effects | 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). | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gender, Nicotine Replacement Therapy, Tobacco Smoking, Smoking stimuli