Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Bupropion; Bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone

Criteria

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.

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.