Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Yale University1 site in 1 country22 target enrollmentDecember 2014

ConditionsBinge Eating Disorder

InterventionsNaltrexone and bupropion combination Pill Placebo

DrugsNaltrexone and bupropion combination

Overview

Phase: Not Applicable
Intervention: Naltrexone and bupropion combination
Conditions: Binge Eating Disorder
Sponsor: Yale University
Enrollment: 22
Locations: 1
Primary Endpoint: Binge Eating Frequency (Continuous)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

September 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
•BMI between 30 kg/m2 and 50 kg/m2
•Not taking anti-depressant medications
•Read English proficiently enough to read study assessments
•Available for duration of treatment plus follow-up period
•Able to travel to study location (New Haven, CT) for monthly visits
•Agree to study procedures

Exclusion Criteria

•Medical status judged by study physician as contraindication
•History of seizures
•Past or current anorexia nervosa, bulimia nervosa
•Current medications that influence eating/weight
•Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
•Pregnant or breastfeeding

Arms & Interventions

Naltrexone/ Bupropion combination

50 mg naltrexone and 300 mg bupropion per day for 3 months

Intervention: Naltrexone and bupropion combination

Pill placebo

Daily placebo medication for 3 months

Intervention: Pill Placebo

Outcomes

Primary Outcomes

Binge Eating Frequency (Continuous)

Time Frame: 6 month follow-up (an average of 6 months following treatment)

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).