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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00006170 |
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 | Intervention | Phase |
---|---|---|
Tobacco Use Disorder |
Behavioral: Bupropion |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control |
Official Title: | Bupropion and Weight Control for Smoking Cessation |
Estimated Enrollment: | 357 |
Study Start Date: | September 2000 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Western Psychiatric Institute & Clinic | |
Pittsburgh, Pennsylvania, United States, 15213 2593 |
Principal Investigator: | Marsha Marcus, Ph.D. | Western Psychiatric Institute & Clinic |
Study ID Numbers: | NIDA-04174-1, R01-04174-1 |
Study First Received: | August 9, 2000 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00006170 History of Changes |
Health Authority: | United States: Federal Government |
Dopamine Uptake Inhibitors Neurotransmitter Agents Tobacco Use Disorder Psychotropic Drugs Disorders of Environmental Origin Body Weight Smoking |
Dopamine Mental Disorders Bupropion Substance-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Pharmacologic Actions |
Mental Disorders Therapeutic Uses Bupropion Substance-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |