Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tabl
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 expe
| Condition(s) | Obesity; Drug, Obesity, Morbid |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 bene |
| Who can participate | 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 p |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Laval University |
| Locations | Québec, Quebec, Canada |
| Start date | 2025-06-04 |
| NCT ID | NCT06620562 |
| Official listing | https://clinicaltrials.gov/study/NCT06620562 |