Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women|
- Subjective effects
- Cognitive performance
- Physiologic measures
- Smoking Behavior
- Plasma Nicotine
|Study Start Date:||May 2004|
|Study Completion Date:||June 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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, 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 suppression and cigarette blunting effects will be compared in women and men.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135746
|United States, Virginia|
|Behavioral Pharmacolgy Research Laboratory|
|Richmond, Virginia, United States, 23298 0205|
|Principal Investigator:||Thomas Eissenberg, Ph.D.||Virginia Commonwealth University|