NCT03047005

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

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 obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Conditions

• Binge-Eating Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NB medication (Naltrexone Bupropion combination)	NB medication
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-08-28
• Primary completion: 2021-12-16
• Completion: 2022-12-16
• First posted: 2017-02-08
• Last updated: 2024-02-02
• Results posted: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study