Adding naltrexone–bupropion extended‑release to sleeve gastrectomy to improve weight loss
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial
This trial will test whether taking naltrexone–bupropion extended‑release after sleeve gastrectomy helps adults with obesity lose more weight and improve related health problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06620562 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blind trial will assign adults undergoing primary sleeve gastrectomy 1:1 to naltrexone–bupropion extended‑release or a matching placebo starting one month after surgery. The medication will be titrated progressively and continued for 24 months, and both groups will receive standardized behavioral and nutritional support. Primary outcomes are excess weight loss at 12 and 24 months and the proportion of patients achieving EWL >50%, with secondary measures including comorbidity resolution and changes in eating behaviors. The study is conducted at Laval University in Québec, Canada.
Who should consider this trial
Good fit: Adults scheduled for primary sleeve gastrectomy with BMI ≥30 kg/m2 plus an obesity‑related comorbidity or BMI ≥35 kg/m2 without comorbidities who can start medication one month after surgery and commit to 24 months of follow‑up are ideal candidates.
Not a fit: Patients with contraindications such as chronic opioid use, seizure disorder, current or past bulimia/anorexia, pregnancy or planned pregnancy, end‑stage liver or kidney disease, use of interacting drugs, or those undergoing revisional bariatric surgery are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding naltrexone–bupropion could help post‑sleeve patients lose more excess weight, increase the chance of reaching clinically meaningful weight loss, and improve obesity‑related comorbidities and eating behaviors.
How similar studies have performed: Naltrexone–bupropion has proven effective for weight loss in non‑surgical populations, but its routine use after sleeve gastrectomy remains relatively untested with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities. Exclusion Criteria: * 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
Québec, Quebec
- Criucpq-Ul — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Mélanie Nadeau
- Email: melanie.nadeau@criucpq.ulaval.ca
- Phone: 4186568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.