Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

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.

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.