Bupropion and Weight Control for Smoking Cessation - 1

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Disorder

Treatments: Behavioral: weight concerns intervention; Behavioral: smoking cessation intervention; Drug: Bupropion; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006170

R01DA004174 (U.S. NIH Grant/Contract)

NIDA-04174-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 349 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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349 participants in 4 patient groups, including a placebo group

Bupropion and Weight Concerns intervention

Experimental group

Description:

Bupropion SR and a weight concerns psychosocial intervention

Treatment:

Behavioral: weight concerns intervention

Drug: Bupropion

Placebo and Weight Concerns

Active Comparator group

Description:

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

Treatment:

Behavioral: weight concerns intervention

Drug: Placebo

Bupropion and standard smoking cessation

Active Comparator group

Description:

Bupropion SR and a time and attention controlled smoking cessation intervention

Treatment:

Drug: Bupropion

Behavioral: smoking cessation intervention

Placebo and standard smoking cessation

Placebo Comparator group

Description:

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

Treatment:

Behavioral: smoking cessation intervention

Drug: Placebo