Bupropion and Weight Control for Smoking Cessation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

NCT00142870

Marijuana Abuse Substance-Related Disorders

COMPLETED PHASE2

Bupropion for Hospital-Based Smoking Cessation

NCT00261170

Smoking

COMPLETED PHASE3

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

NCT00129272

Tobacco Use Cessation Tobacco Use Disorder

COMPLETED PHASE2

A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder

NCT00593099

Bipolar Disorder

COMPLETED PHASE1/PHASE2

STOP Study: Effectiveness of Zyban in a Clinical Population

NCT01015170

Cigarette Smoking Nicotine Addiction Smoking Cessation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bupropion and Weight Concerns intervention

Bupropion SR and a weight concerns psychosocial intervention

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

smoking cessation medication aid

weight concerns intervention

Intervention Type BEHAVIORAL

cognitive behavioral treatment to address weight concners

Placebo and Weight Concerns

A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

A matched placebo pill

weight concerns intervention

Intervention Type BEHAVIORAL

cognitive behavioral treatment to address weight concners

Bupropion and standard smoking cessation

Bupropion SR and a time and attention controlled smoking cessation intervention

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

smoking cessation medication aid

smoking cessation intervention

Intervention Type BEHAVIORAL

Cognitive behavioral intervention for smoking cessation

Placebo and standard smoking cessation

A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A matched placebo pill

smoking cessation intervention

Intervention Type BEHAVIORAL

Cognitive behavioral intervention for smoking cessation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupropion

smoking cessation medication aid

Intervention Type DRUG

Placebo

A matched placebo pill

Intervention Type DRUG

weight concerns intervention

cognitive behavioral treatment to address weight concners

Intervention Type BEHAVIORAL

smoking cessation intervention

Cognitive behavioral intervention for smoking cessation

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

zyban

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No