Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Phase 2

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination; Other: Placebo

• Registration Number: NCT03539900
• Lead Sponsor: Yale University

Brief Summary

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Detailed Description

Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Study Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Primary Completion: 2022-04-19
• Study Completion: 2023-03-22
• Results First Submitted: 2023-04-17
• Results First Submitted QC: 2023-06-30
• Results First Posted: 2023-07-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
• BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
• Available for the duration of the treatment and follow-up (15 months);
• Read, comprehend, and write English at a sufficient level to complete study-related materials.

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Exclusion Criteria

• Currently taking opioid pain medications or drugs; or positive drug screen for opiates
• Currently taking medications that influence eating/weight;
• History of seizures;
• Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
• Past or current anorexia nervosa or bulimia nervosa;
• Pregnant or breastfeeding;
• Medical status judged by study physician as contraindication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NB Medication	Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination	Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Placebo	Placebo	Placebo will be inactive and taken daily in pill form.

Primary Outcome Measures

Name	Time	Method
Percent BMI Change	Post-treatment (3 months)	BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Change in Binge Eating Frequency	Post-treatment (3 months)	Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	12 months post-treatment	BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 12 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Change in Binge Eating Frequency	12 months post-treatment	Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.

Trial Locations

Locations (1)

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