NCT04599478

Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.

Detailed description

Participants who provide informed consent and are determined to be eligible will then participate in the study. A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type.

Conditions

• Loss-of-control Eating
• Obesity/Overweight

Interventions

Type	Name	Description
DRUG	Naltrexone and Bupropion medication	NB medication will be taken daily in pill form.
BEHAVIORAL	Behavioral Weight Loss	Behavioral Weight Loss (BWL) counseling includes weekly sessions.
OTHER	Placebo	Placebo will be inactive and taken daily in pill form.

Timeline

• Start date: 2021-06-29
• Primary completion: 2025-12-12
• Completion: 2027-01-01
• First posted: 2020-10-22
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study