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Completed

NCT Number: NCT00414167

Craving, Binge Eating and Obesity

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.

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Key information

Conditions

Binge Eating Disorder Behavior Binge-Eating Disorder Body Weight Bulimia Emotional Eating Feeding Behavior Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupropion

Drug

300 mg per day for 8 weeks

Other names: wellbutrin, zyban

Placebo

Other

Placebo

Primary outcomes

  1. Frequency of Binge Eating Episodes

    Time frame: One week (at post treatment)

Secondary outcomes

  1. Percent BMI Loss

    Time frame: 8 weeks (baseline and 8 weeks)

    Percent loss in Body Mass Index

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Dec 21, 2006
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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