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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: March 2008

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(s) in this Clinical Trial

• Drug: nicotine transdermal system

Primary Measures

• Subjective effects
• Cognitive performance
• Heart Rate
• Expired Air Carbon Monoxide Level
• Plasma Nicotine
• Smoking Behavior

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Thomas E Eissenberg, PhD Principal Investigator Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00390559

Study ID Number: NIDA-11082-3

ClinicalTrials.gov Identifier: NCT00390559

Health Authority: United States: Federal Government