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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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT05295875 - Efficacy and Safety of ALT-801 in the Treatment of Obesity Phase 2
Enrolling by invitation NCT04599504 - Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) Phase 2/Phase 3
Enrolling by invitation NCT04605081 - Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a) Phase 2/Phase 3