[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563776":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Laval University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Naltrexone\u002FBupropion","EXPERIMENTAL","Patients will be started one month after sleeve gastrectomie on a progressive dose of Naltrexone\u002FBupropion extended-release 8mg\u002F90mg, up to 2 tabs twice a day (32mg\u002F360mg) adjusted according to tolerance and side-effects.",[13],"Drug: Naltrexone\u002FBupropion",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will be started one month after sleeve gastrectomie on a progressive numbers of matched placebo tablets up to 2 tabs twice a day",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patient randomized in the Neltrexone\u002FBupropion group will be started one month after surgery on a progressive dose of Naltrexone\u002FBupropion extended-release 8mg\u002F90mg, up to 2 tabs twice a day (32mg\u002F360mg) adjusted according to tolerance and side-effects to improve long-term use. Duration of therapy will be 24 months.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Mélanie Nadeau","CONTACT","4186568711","melanie.nadeau@criucpq.ulaval.ca",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Criucpq-Ul","RECRUITING","Québec","Quebec","G1V 4G5","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-71.21454,46.81228,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Laurent Biertho","Principal Investigator",[57],{"name":58,"class":59},"Bausch Health Americas, Inc.","INDUSTRY","100563776","phase-4-improving-efficacity-of-sleeve-gastrectomy-with-naltrexonebupropion-extended-release-tablet-100563776",false,"NCT06620562","Improving Efficacity of Sleeve Gastrectomy With Naltrexone\u002FBupropion Extended-release Tablet","Improving Efficacity of Sleeve Gastrectomy With Naltrexone\u002FBupropion Extended-release Tablet - A Randomized Controlled Trial","Inclusion Criteria:\n\n* MBI above 30 kg\u002Fm2 with obesity-related comorbidity or above 35 kg\u002Fm2 without associated comorbidities.\n\nExclusion Criteria:\n\n* Revisional or reoperative surgery\n* Pregnancy or planned pregnancy in the next 24 months\n* Simultaneous use of other weight loss medication\n* Uncontrolled hypertension\n* Chronic opioid use or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal.\n* Use of other bupropion-containing products\n* Concomitant administration of monoamine oxidase inhibitors.\n* End-stage liver or kidney disease\n* Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel)\n* Concomitant administration of the antipsychotic thioridazine\n* Seizure disorder or a history of seizures\n* Cardiac pacemaker\n* Current or prior diagnosis of bulimia or anorexia nervosa","ALL","18 Years","65 Years",{"count":71,"type":72},108,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","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.\n\nResearchers 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.\n\nParticipants 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\u002FBupropion extended-release or placebo. Duration of therapy will be 24 months.Both groups will benefit from behavioral and nutritional support.",[78,79],"Obesity; Drug","Obesity, Morbid","2025-08-04",{"date":82,"type":83},"2025-08-08","ACTUAL",{"date":85,"type":83},"2025-06-04",{"date":87,"type":72},"2028-08",{"name":5,"class":6},1]