NCT03539900

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination	NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
OTHER	Placebo	Placebo will be inactive and taken daily in pill form.

Timeline

• Start date: 2018-04-17
• Primary completion: 2022-04-19
• Completion: 2023-03-22
• First posted: 2018-05-29
• Last updated: 2024-04-03
• Results posted: 2023-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study