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

Obesity/Overweight Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Loss-of-control Eating
• Obesity/Overweight
• Overweight

• NCT number: NCT04599478
• Study type: Interventional
• Source: Yale University
• Contact: Valentina Ivezaj, Ph.D.
• Phone: 203-785-7210
• Email: valentina.ivezaj@yale.edu
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 29, 2021
• Completion date: January 2027