Bupropion and Weight Control for Smoking Cessation - 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bupropion and Weight Control for Smoking Cessation

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Bupropion
* Drug: Placebo
* Behavioral: weight concerns intervention
* Behavioral: smoking cessation intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion and Weight Concerns intervention<br>Bupropion SR and a weight concerns psychosocial intervention | Drug: Bupropion<br>* smoking cessation medication aid<br>* Other names: zyban;Behavioral: weight concerns intervention<br>* cognitive behavioral treatment to address weight concners<br>|
| Active Comparator: Placebo and Weight Concerns<br>A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion | Drug: Placebo<br>* A matched placebo pill<br>Behavioral: weight concerns intervention<br>* cognitive behavioral treatment to address weight concners<br>|
| Active Comparator: Bupropion and standard smoking cessation<br>Bupropion SR and a time and attention controlled smoking cessation intervention | Drug: Bupropion<br>* smoking cessation medication aid<br>* Other names: zyban;Behavioral: smoking cessation intervention<br>* Cognitive behavioral intervention for smoking cessation<br>|
| Placebo Comparator: Placebo and standard smoking cessation<br>A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention | Drug: Placebo<br>* A matched placebo pill<br>Behavioral: smoking cessation intervention<br>* Cognitive behavioral intervention for smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | 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. | 3 months | 
| Smoking Abstinence | 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. | 6 months | 
| Smoking Abstinence | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, Women, bupropion, weight concerns, weight