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

Not Applicable

Completed

• Conditions: Binge Eating Disorder
• Interventions: Other: Pill Placebo; Drug: Naltrexone and bupropion combination

• Registration Number: NCT02317744
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-16
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-10-13
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Results First Posted: 2017-12-22
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pill placebo	Pill Placebo	Daily placebo medication for 3 months
Naltrexone/ Bupropion combination	Naltrexone and bupropion combination	50 mg naltrexone and 300 mg bupropion per day for 3 months

Primary Outcome Measures

Name	Time	Method
Binge Eating Frequency (Continuous)	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).

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	6 month follow-up (an average of 6 months following treatment)	BMI is calculated using measured height and weight.

Trial Locations

Locations (1)

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