Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated
strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients
with BED are needed that can produce sustained clinical outcomes and promote weight loss.
This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss
(BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved
anti-obesity combination medication), alone and in combination, for the treatment of BED in
patients with obesity. The acute treatment stage stage RCT will provide new findings
regarding the effectiveness of NB medication and whether this specific combination of BWL and
NB medication is effective for patients with obesity and BED. N=160 patients with BED and
obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design
trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study
will produce important new information about the relative efficacy of BWL and this recently
FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with
obesity.

Inclusion Criteria:

- Binge eating disorder (full criteria as described in the American Psychiatric
Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)

- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;

- Available for the duration of the treatment and follow-up (20 months);

- Read, comprehend, and write English at a sufficient level to complete study-related
materials;

- Able to travel to study location (New Haven, CT) for weekly visits.

Exclusion Criteria:

- Currently taking anti-depressant medications;

- Currently taking opioid pain medications or drugs;

- 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, bulimia nervosa;

- Pregnant or breastfeeding;

- Medical status judged by study physician as contraindication.