Overview

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.