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

Laval University

Status and phase: Enrolling; Phase 4

Conditions: Obesity; Drug; Obesity, Morbid

Treatments: Drug: Placebo; Drug: Naltrexone/Bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT06620562

Sleeve-Plus

Details and patient eligibility

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Naltrexone/Bupropion

Experimental group

Description:

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.

Treatment:

Drug: Naltrexone/Bupropion

Placebo

Placebo Comparator group

Description:

Patients will be started one month after sleeve gastrectomie on a progressive numbers of matched placebo tablets up to 2 tabs twice a day

Treatment:

Drug: Placebo