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.

Condition	Intervention
Tobacco Use Disorder	Drug: nicotine transdermal system

Further Study Details: 

Primary Outcomes: Subjective effects; Cognitive performance; Physiologic measures; Smoking Behavior; Plasma Nicotine
Expected Total Enrollment:  128

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 withdrawl 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 supression and cigarette blunting effects will be compared in women and men.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Daily cigarette use of 15 or more cigarettes for at least 2 years
• Screening CO level of or greater than 15 ppm
• Normal or corrected-to-normal vision
• Willing to abstain from tobacco products for 8 or more hours prior to testing

Exclusion Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00135746

Virginia
      Behavioral Pharmacolgy Research Laboratory, Richmond,  Virginia,  23298 0205,  United States; Recruiting

Study chairs or principal investigators

Thomas Eissenberg, Ph.D.,  Principal Investigator,  Virginia Commonwealth University   

Study ID Numbers:  NIDA-11082-2; R01-11082-2
Last Updated:  August 25, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00135746
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30