Actively Recruiting
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Led by Laval University · Updated on 2025-08-08
108
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
B
Bausch Health Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Body mass index (BMI) above 30 kg/m2 with obesity-related health conditions or above 35 kg/m2 without such conditions
You will not qualify if you...
- Previous revisional or reoperative surgery
- Pregnancy or planning pregnancy in the next 24 months
- Use of other weight loss medications
- Uncontrolled high blood pressure
- Chronic use of opioids or opioid agonists, or acute opioid withdrawal
- Use of other bupropion-containing products
- Use of monoamine oxidase inhibitors
- End-stage liver or kidney disease
- Use of CYP2B6 inhibitors (ticlopidine or clopidogrel)
- Use of the antipsychotic thioridazine
- History of seizures or seizure disorder
- Presence of a cardiac pacemaker
- Current or past diagnosis of bulimia or anorexia nervosa
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Criucpq-Ul
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
M
Mélanie Nadeau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here