Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Binge-Eating Disorder

Treatments: Other: Placebo; Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03539900

R01DK112771 (U.S. NIH Grant/Contract)

2000021769

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 2 patient groups, including a placebo group

NB Medication

Experimental group

Description:

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Treatment:

Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Placebo

Placebo Comparator group

Description:

Placebo will be inactive and taken daily in pill form.

Treatment:

Other: Placebo