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

NCT06620562 | Recruiting Phase 4

• 1 other identifier: Sleeve-Plus
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Drug; Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Weight loss

  % Excess weight loss

  baseline to 24 months

• Percentage of participant with an Excess Weight Loss above 50%

  Baseline to 24 months

Secondary Outcomes (10)

• Resolution of associated comorbidities

  Baseline to 24 months

• Improvement of Eating behaviors (Food Craving State Questionnaire)

  Baseline to 24 months

• Improvement of Eating behaviors (Food Craving Trait Questionnaire)

  Baseline to 24 months

• Decrease in food explicit and implicit wanting and liking food reward.

  Baseline to 24 month

• Improvement in well-being, mood and Quality of Life (SF-36)

  Baseline to 24 months

Study Arms (2)

Naltrexone/Bupropion

EXPERIMENTAL

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.

Drug: Naltrexone/Bupropion

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

Drug: Placebo

Interventions

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.

Naltrexone/Bupropion

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Bausch Health Canada: collaborator

Study Sites (1)

Criucpq-Ul

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Naltrexone; Bupropion

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Central Study Contacts

Mélanie Nadeau

CONTACT

4186568711; melanie.nadeau@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center double-blind randomized placebo-controlled trial.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: October 1, 2024
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CA (1)