RecruitingPhase 4NCT06620562

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

Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial

Sponsor

Laval University

Enrollment

108 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity, Morbid Obesity; Drug

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 benefit from behavioral and nutritional support.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.

Exclusion Criteria13

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNaltrexone/Bupropion

Patient randomized in the Neltrexone/Bupropion group will be started one month after surgery on a progressive dose of Naltrexone/Bupropion extended-release 8mg/90mg, up to 2 tabs twice a day (32mg/360mg) adjusted according to tolerance and side-effects to improve long-term use. Duration of therapy will be 24 months.

DRUGPlacebo

Patient randomized in the placebo group will be started one month after surgery on a progressive numbers of matched placebo tablets up to 2 tabs twice a day. Duration of therapy will be 24 months.