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

Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Obesity; Drug
• Intervention / Treatment: Drug: Naltrexone/Bupropion; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mélanie Nadeau; Phone Number: 4186568711; Email: melanie.nadeau@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Recruiting
      • Criucpq-Ul
      • Contact: Mélanie Nadeau; Phone Number: 4186568711; Email: melanie.nadeau@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 Comparator: 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	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	% Excess weight loss	baseline to 24 months
Percentage of participant with an Excess Weight Loss above 50%		Baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of associated comorbidities	Type 2 diabetes, hypertension and dislipidemia	Baseline to 24 months
Improvement of Eating behaviors (Food Craving State Questionnaire)	Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome.	Baseline to 24 months
Improvement of Eating behaviors (Food Craving Trait Questionnaire)	Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome.	Baseline to 24 months
Decrease in food explicit and implicit wanting and liking food reward.	Decrease in food explicit and implicit wanting and liking food reward assessed by Leeds Food Preference Questionnaire using a computerized behavioural task	Baseline to 24 month
Improvement in well-being, mood and Quality of Life (SF-36)	36-item short form survey evaluating quality of life on a scale from 0 to 100, higher scores indicate better quality of life	Baseline to 24 months
Improvement in well-being, mood and Quality of Life (QLaval)	Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life	Baseline to 24 months
Improvement in well-being, mood and Quality of Life (HAD questionnaire)	HAD questionnaire includes 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), obtaining two scores (maximum score of each score = 21). Higher scores indicate a worse outcome	Baseline to 24 months
Gastro-intestinal side-effects	Gastro-intestinal side-effects assessed by GIQLI questionnaire on a scale from 0 to 144. Higher scores indicate better quality of life	Baseline to 24-month
Improvement of Eating behaviors (Binge Eating Scale)	To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder. The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to say if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level.	Baseline to 24 months
Improvement of Eating behaviors (YFAS 2.0)	The YFAS 2.0 was designed to assess food addiction. It assesses the symptoms of food addiction and the resulting distress and impaired functioning. The higher the level of symptoms, the more severe the food addiction. Impaired functioning and distress are scored from 0 to 2. Symptoms are scored from 0 to 11. If the functioning and distress score is 1 and above, the food addiction may be mild (2-3 symptoms), moderate (4-5 symptoms), or severe (6+ symptoms).	Baseline to 24 months

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Bausch Health Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Cytochrome P-450 Enzyme Inhibitors; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Antidepressive Agents; Alcohol Deterrents; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Narcotic Antagonists; Naltrexone; Bupropion
• Other Study ID Numbers: Sleeve-Plus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No