Craving, Binge Eating and Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414167
• Other study ID #: 0511000832
• Secondary ID: K23DK071646
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2005
• Est. completion date: March 2011

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity

Intervention

Drug:
• bupropion
300 mg per day for 8 weeks

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Binge Eating Episodes		One week (at post treatment)
Secondary	Percent BMI Loss	Percent loss in Body Mass Index	8 weeks (baseline and 8 weeks)