NCT05157698

Pharmacological and Behavioral Treatment After Bariatric Surgery

Behavioral and Pharmacological Treatments to Enhance Weight Outcomes After Metabolic and Bariatric Surgery

• Status: 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 treatment, alone and combined, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning following metabolic and bariatric surgery.

Detailed description

Metabolic and bariatric surgery is currently the most effective treatment for severe obesity; however, a substantial proportion of patients attain suboptimal weight losses and continue to struggle with obesity, weight regain, and related medical comorbidities after surgery. Thus, this study aims to perform a randomized double-blind placebo-controlled study to test the effectiveness of a rigorous manualized behavioral weight loss treatment and a FDA-approved weight loss agent (naltrexone+bupropion), alone and in combination, for improving weight loss, cardiovascular risk factors, and psychosocial functioning after metabolic and bariatric surgery. This study will produce important new clinical findings regarding the utility and effectiveness of pharmacotherapy and behavioral weight loss for a rapidly growing obesity subgroup and will inform care models for managing chronic and refractory obesity to enhance outcomes after metabolic and bariatric surgery.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Naltrexone and Bupropion Combination	Participants in this intervention will take active naltrexone and bupropion pills.
BEHAVIORAL	Behavioral Weight Loss	Participants in this intervention will receive behavioral weight loss treatment.
OTHER	Placebo	Participants in this intervention will take inactive (placebo) pills.

Timeline

• Start date: 2022-01-13
• Primary completion: 2027-01-12
• Completion: 2028-01-12
• First posted: 2021-12-15
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study