NCT04662801

Weight Regain Treatment Post-Bariatric Surgery

A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Conditions

• Obesity, Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Weight Loss (BWL)	All participants will receive twelve weeks of BWL treatment.
BEHAVIORAL	Early Responder: BWL continued	Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
COMBINATION_PRODUCT	Early Non-responder: BWL continued with medication added	Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.

Timeline

• Start date: 2021-08-05
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2020-12-10
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study