NCT03045341

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

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

Detailed description

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.

Conditions

• Binge-eating Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NB medication (Naltrexone Bupropion combination)	NB medication
BEHAVIORAL	Behavioral Weight Loss (BWL) counseling	BWL counseling
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-02-27
• Primary completion: 2021-07-23
• Completion: 2022-12-16
• First posted: 2017-02-07
• Last updated: 2023-03-08
• Results posted: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study