Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Obesity; Drug, Obesity, Morbid
In brief
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.
Key facts
- Study ID
- NCT06620562
- Run by
- Laval University
- People needed
- 108
- Starts
- 2025-06-04
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
You may not qualify 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 it is running
- Criucpq-Ul — Québec, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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