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Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet

RecruitingPhase 4Ages 18 Years - 65 YearsAllLaval University
NCT06620562 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Naltrexone/Bupropion
  • Placebo
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Where

1 site
Criucpq-Ul
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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