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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: bupropion
  • 300 mg per day for 8 weeks
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Bupropion
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Frequency of binge eating episodes
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Body weight, food cravings, emotional eating
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Marney A. White, PhD Principal Investigator Yale University  

Overall Contact: Dr. Marney A White, PhD 203-785-4349 Marney.White@yale.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414167

Study ID Number: DK71646

ClinicalTrials.gov Identifier: NCT00414167

Health Authority: United States: Federal Government