NCT03946111

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo.

Conditions

• Binge-Eating Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	Naltrexone and Bupropion	Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
OTHER	Placebo	Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.

Timeline

• Start date: 2019-08-07
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2019-05-10
• Last updated: 2026-01-09
• Results posted: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study