Clinical trial NCT06620562: Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Official title: Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Obesity; Drug
Obesity, Morbid
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Bausch Health Canada
First posted: 2024-10-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center double-blind randomized placebo-controlled trial.
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Weight loss
timeFrame: baseline to 24 months
measure: Percentage of participant with an Excess Weight Loss above 50%
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Resolution of associated comorbidities
timeFrame: Baseline to 24 months
measure: Improvement of Eating behaviors (Food Craving State Questionnaire)
timeFrame: Baseline to 24 months
measure: Improvement of Eating behaviors (Food Craving Trait Questionnaire)
timeFrame: Baseline to 24 months
measure: Decrease in food explicit and implicit wanting and liking food reward.
timeFrame: Baseline to 24 month
measure: Improvement in well-being, mood and Quality of Life (SF-36)
timeFrame: Baseline to 24 months
measure: Improvement in well-being, mood and Quality of Life (QLaval)
timeFrame: Baseline to 24 months
measure: Improvement in well-being, mood and Quality of Life (HAD questionnaire)
timeFrame: Baseline to 24 months
measure: Gastro-intestinal side-effects
timeFrame: Baseline to 24-month
measure: Improvement of Eating behaviors (Binge Eating Scale)
timeFrame: Baseline to 24 months
measure: Improvement of Eating behaviors (YFAS 2.0)
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
Study officials:
References: