Behavioral and Pharmacological Treatments to Enhance Weight Outcomes After Metabolic and Bariatric Surgery
Yale University
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.
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 psychosoci…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up) * Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2 * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy * Suboptimal weight outcomes after MBS * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory st…
Interventions
- DrugNaltrexone and Bupropion Combination
Participants in this intervention will take active naltrexone and bupropion pills.
- BehavioralBehavioral Weight Loss
Participants in this intervention will receive behavioral weight loss treatment.
- OtherPlacebo
Participants in this intervention will take inactive (placebo) pills.
Location
- Yale School of MedicineNew Haven, Connecticut