Craving, Binge Eating and Obesity

Phase 2

Completed

• Conditions: Binge Eating Disorder; Obesity
• Interventions: Other: Placebo; Drug: bupropion

• Registration Number: NCT00414167
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-10-22
• Results First Submitted QC: 2014-02-12
• Results First Posted: 2014-03-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	bupropion	Bupropion

Primary Outcome Measures

Name	Time	Method
Frequency of Binge Eating Episodes	One week (at post treatment)

Secondary Outcome Measures

Name	Time	Method
Percent BMI Loss	8 weeks (baseline and 8 weeks)	Percent loss in Body Mass Index

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States