Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06620562

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity; Drug, Obesity, Morbid

Full registry criteria

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

Treatments and study arms

Naltrexone/Bupropion

Drug

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.

Placebo

Drug

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.

Primary outcomes

Weight lossbaseline to 24 months

% Excess weight loss

Percentage of participant with an Excess Weight Loss above 50%Baseline to 24 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Criucpq-Ul🇨🇦 Québec, Quebec, Canada

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Mélanie NadeauContact

Email · Call 4186568711