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Bupropion and Weight Control for Smoking Cessation - 1
This study is currently recruiting patients.
Sponsored by: | National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
Purpose
The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
Condition | Treatment or Intervention | Phase |
---|---|---|
Tobacco Use Disorder |
Behavior: Bupropion |
Phase IV |
MedlinePlus related topics: Smoking
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control
Official Title: Bupropion and Weight Control for Smoking Cessation
Expected Total Enrollment: 450
Study start: September 2000;
Study completion: June 2004
Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
http://www.wpic.pitt.edu/research/wscp/default.htm
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