Tests naltrexone with bupropion after sleeve gastrectomy for obesity
Tests naltrexone with bupropion pills after weight-loss surgery in adults with obesity.
Plain-language title generated from the registry record
Registry title: Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Key facts
- Where
- Québec, CanadaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06620562, who can take part
Where in Canada
- Criucpq-UlQuébec, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Laval University
- Trial code
- NCT06620562
- Record updated
- 8 August 2025
- Original description
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.Read full original descriptionShow less
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial
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.
Inclusion: MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
Exclusion: Revisional or reoperative surgery; Simultaneous use of other weight loss medication; Concomitant administration of monoamine oxidase inhibitors; Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel); Concomitant administration of the antipsychotic thioridazine; Current or prior diagnosis of bulimia or anorexia nervosa; Uncontrolled hypertension; End-stage liver or kidney disease; Seizure disorder or a history of seizures; Cardiac pacemaker; Pregnancy or planned pregnancy in the next 24 months; 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.