Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Recruiting now Phase 4 NCT06620562
Run by Laval University · for 18 to 65 · All sexes
What this study is about
The goal of this clinical trial is to assess the impact of combination therapy with Naltrexone-Bupropion (NB) in the post-operative period of sleeve gastrectomy (SG). on a) weight loss, b) resolution of comorbidities and c) eating behaviors. Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss (EWL) at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50% in the SG-NB group versus in the SG-placebo group. Participants will be randomized 1:1 to SG in combination with NB versus SG with placebo. Patients will be started one month after surgery on a progressive dose of Naltrexone/Bupropion extended-release or placebo. Duration of therapy will be 24 months.Both groups will benefit from behavioral and nutritional support.
Who can join (things the study team will check)
✅ You may be able to join if…
- MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
🚫 You may not be able to join if…
- Revisional or reoperative surgery
- Pregnancy or planned pregnancy in the next 24 months
- Simultaneous use of other weight loss medication
- Uncontrolled hypertension
- Chronic opioid use or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal.
- Use of other bupropion-containing products
- Concomitant administration of monoamine oxidase inhibitors.
- End-stage liver or kidney disease
- Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel)
- Concomitant administration of the antipsychotic thioridazine
- Seizure disorder or a history of seizures
- Cardiac pacemaker
- Current or prior diagnosis of bulimia or anorexia nervosa
Where this trial is running
- Criucpq-Ul, Québec, Quebec, Canada
Who to contact
Mélanie Nadeau · 4186568711 · melanie.nadeau@criucpq.ulaval.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06620562.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.