Conditions: Tobacco Use Disorder
Keywords: smoking cessation Women bupropion weight concerns weight
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 349
Healthy volunteers: no

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.

Arms:
arm 1: Bupropion SR and a weight concerns psychosocial intervention arm 2: A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion arm 3: Bupropion SR and a time and attention controlled smoking cessation intervention arm 4: A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention

Interventions: intervention 1: Bupropion intervention 2: Placebo intervention 3: weight concerns intervention intervention 4: smoking cessation intervention
Intervention descriptions: intervention 1: smoking cessation medication aid intervention 2: A matched placebo pill intervention 3: cognitive behavioral treatment to address weight concners intervention 4: Cognitive behavioral intervention for smoking cessation

Protocol document: