Craving, Binge Eating and Obesity

Study Overview
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Brief Summary
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This research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. Participants in the study will receive either bupropion or placebo (sugar pill, inactive medication) as an outpatient for eight weeks. In addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. This treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost. It is expected that compared to placebo, bupropion will produce greater reductions in binge eating.

Detailed Description
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The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge eating episodes, bupropion is a promising psychopharmacological agent in treating binge eating and reducing weight. It is hypothesized that compared to placebo, bupropion will produce significantly greater reductions in the frequency of binge eating. Secondary goals are to explore interrelationships between treatment and changes in cravings, frequency of binge episodes, emotional eating, and weight loss. Following the medication phase of the trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered by doctoral-level psychologists specializing in eating disorders and weight management.

Official Title
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Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder

Conditions
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Binge Eating Disorder, Obesity

Intervention / Treatment
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* Drug: bupropion
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25-50 Able to travel to clinical site (New Haven, CT) for bi-weekly visits. Exclusion Criteria: Predisposition to seizures History of anorexia or bulimia nervosa Current Type I or Type II diabetes mellitus

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bupropion | Drug: bupropion<br>* 300 mg per day for 8 weeks<br>* Other names: zyban;|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Binge Eating Episodes |  | One week (at post treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent BMI Loss | Percent loss in Body Mass Index | 8 weeks (baseline and 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge eating, Obesity, Medication, Craving, Emotional eating