Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery
Trial Summary
What is the purpose of this trial?
This trial tests a special program and two medications to help people lose weight after weight-loss surgery. It targets patients who still struggle with obesity despite having surgery. The program helps change daily habits, while the medications reduce hunger and cravings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that are a contraindication to NB medication (like MAOIs or opiates) or if you are using other weight loss medications.
What data supports the effectiveness of this treatment for obesity after bariatric surgery?
Is the combination of behavioral therapy and pharmacological treatment safe for humans after bariatric surgery?
How is Behavioral Weight Loss Therapy different from other treatments for weight regain after bariatric surgery?
Behavioral Weight Loss Therapy is unique because it focuses on changing lifestyle habits and behaviors to manage weight regain after bariatric surgery, rather than relying solely on medication or surgery. This approach can help patients achieve long-term weight management by addressing the underlying behaviors that contribute to weight gain.12689
Research Team
Valentina Ivezaj, Ph.D.
Principal Investigator
Yale University
Eligibility Criteria
This trial is for adults with obesity who've had bariatric surgery but haven't achieved desired weight loss. Participants must have a BMI between 27-50, be in good health, and willing to follow the study plan for up to 18 months. Women must use effective contraception; men should ensure contraception with partners.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 months of either NB medication, Behavioral Weight Loss counseling, or a combination, with daily pill intake
Follow-up
Participants are monitored for changes in depressive symptoms, cholesterol, HbA1C, BMI, and other health metrics
Treatment Details
Interventions
- Behavioral Weight Loss (Behavioral Intervention)
- Naltrexone and Bupropion Combination (Combination Drug)
- Placebo (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator