Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
NCT ID: NCT06620562
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
108 participants
INTERVENTIONAL
2025-06-04
2028-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naltrexone/Bupropion
Patients will be started one month after sleeve gastrectomie 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.
Naltrexone/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.
Placebo
Patients will be started one month after sleeve gastrectomie on a progressive numbers of matched placebo tablets up to 2 tabs twice a day
Placebo
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.
Interventions
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Naltrexone/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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bausch Health Canada
UNKNOWN
Laval University
OTHER
Responsible Party
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Laurent Biertho
Principal Investigator
Locations
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Criucpq-Ul
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Sleeve-Plus
Identifier Type: -
Identifier Source: org_study_id
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