Bupropion and Weight Control for Smoking Cessation - 1

Phase 4

Completed

Conditions: Tobacco Use Disorder

Interventions: Drug: Placebo
Drug: Bupropion
Behavioral: weight concerns intervention
Behavioral: smoking cessation intervention

Registration Number: NCT00006170

Lead Sponsor: University of Pittsburgh

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 349

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bupropion and Weight Concerns intervention	weight concerns intervention	Bupropion SR and a weight concerns psychosocial intervention
Placebo and Weight Concerns	Placebo	A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
Placebo and Weight Concerns	weight concerns intervention	A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
Bupropion and standard smoking cessation	Bupropion	Bupropion SR and a time and attention controlled smoking cessation intervention
Bupropion and standard smoking cessation	smoking cessation intervention	Bupropion SR and a time and attention controlled smoking cessation intervention
Placebo and standard smoking cessation	Placebo	A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
Placebo and standard smoking cessation	smoking cessation intervention	A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
Bupropion and Weight Concerns intervention	Bupropion	Bupropion SR and a weight concerns psychosocial intervention

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	12 months	Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

Secondary Outcome Measures