Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaval University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
Disqualifiers
Revisional or reoperative surgery
Pregnancy or planned pregnancy in the next 24 months
Simultaneous use of other weight loss medication
Uncontrolled hypertension
Trial design
Design model
Parallel
Treatments tested in this trial
Naltrexone/Bupropion
DrugPatient 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
DrugPatient 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Naltrexone/BupropionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight loss
% Excess weight loss
Time frame
baseline to 24 months2
Percentage of participant with an Excess Weight Loss above 50%
Time frame
Baseline to 24 monthsSecondary outcomes
1
Resolution of associated comorbidities
Type 2 diabetes, hypertension and dislipidemia
Time frame
Baseline to 24 months2
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.
Time frame
Baseline to 24 months3
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.
Time frame
Baseline to 24 months4
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
Time frame
Baseline to 24 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laval University
Lead sponsor
Bausch Health Americas, Inc.
Collaborator
Source ClinicalTrials.gov