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Home > "B" Clinical Trials Conditions > Bupropion and Weight Control for Smoking Cessation - 1 Bupropion and Weight Control for Smoking Cessation - 1
Bupropion and Weight Control for Smoking Cessation - 1
For Condition: Tobacco Use Disorder
Status: Recruiting
Sponsor(s): National Institute on Drug Abuse (NIDA) ,
Synopsis: Smoking Cessation for Women
Details: 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:
Study Type: Interventional, Treatment, Randomized, Placebo Control
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Female
Protocol Entry Criteria: Please contact site for information Inclusion Criteria: 1. Female 2. 18-65 years of age 3. Smoke at least 20 cigarettes per day 4. Report concern about cessation-related weight gain 5. Motivated to quit smoking Exclusion Criteria: 1. Currently pregnant, lactating, or no medically approved method of contraception 2. Major medical problem 3. History of seizure disorder or head injury 4. Current or historical psychosis or bipolar disorder 5. History of alcohol or substance abuse within previous year 6. Current or historical eating disorder 7. Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month 8. Multiple Drug Allergies 9. Current major depressive disorder
Total Enrollment: 450
Location and Contact Information:
Overall Study Official:
MarshaMarcus, Principal Investigator, Western Psychiatric Institute & Clinic
Western Psychiatric Institute & Clinic *Recruiting*
Pittsburgh, Pennsylvania, 15213 2593
United States
Recruiting
Additional Information:
Study ID Numbers: NIDA-04174-1; R01-04174-1
Study Start Date: September 2000
Record last reviewed: September 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006170
Other Tobacco Use Disorder Studies:
1. Combining a Smoke Ending Aid with Behavioral Treatment - 1
2. Chemical Dependency and Smoking Cessation: Patient's Views - 1
3. Bupropion and Weight Control for Smoking Cessation - 1
4. Role of Metabolites in Nicotine Dependence (4) - 13
5. The effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers. - 1
Related Studies:
Other Tobacco Use Disorder Clinical Trials
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Bupropion and Weight Control for Smoking Cessation - 1
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