Bupropion and Weight Control for Smoking Cessation - 1
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Use Disorder
Intervention: Bupropion (Behavioral)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Marsha Marcus, Ph.D., Principal Investigator, Affiliation: Western Psychiatric Institute & Clinic
Summary
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.
Clinical Details
Official title: Bupropion and Weight Control for Smoking Cessation
Study design: Treatment, Randomized, Placebo Control
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Smoke at least 10 cigarettes per day
- Report concern about cessation-related weight gain
- Motivated to quit smoking
Exclusion Criteria:
- Currently pregnant, lactating, or no medically approved method of contraception
- Major medical problem
- History of seizure disorder or head injury
- Current or historical psychosis or bipolar disorder
- History of alcohol or substance abuse within previous year
- Current or historical eating disorder
- Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous
month
- Multiple Drug Allergies
- Current major depressive disorder
Locations and Contacts
Western Psychiatric Institute & Clinic, Pittsburgh, Pennsylvania 15213 2593, United States
Additional Information
Starting date: September 2000
Last updated: November 3, 2005
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