NCT04605081

Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Conditions

• Loss-of-Control Eating
• Obesity/Overweight

Interventions

Type	Name	Description
DRUG	Naltrexone and Bupropion (NB) medication	NB medication will be taken daily in pill form.
OTHER	Placebo	Placebo will be inactive and taken daily in pill form.

Timeline

• Start date: 2022-01-10
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2020-10-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study