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Recruiting NCT06620562

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

Phase IV Interventional Obesity; Drug Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naltrexone/Bupropion, Placebo.
Who it may be relevant to
Registry conditions: Obesity; Drug, Obesity, Morbid. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Weight loss [Time frame: baseline to 24 months]
  • Percentage of participant with an Excess Weight Loss above 50% [Time frame: Baseline to 24 months]
Secondary outcome measures (10)
  • Resolution of associated comorbidities [Time frame: Baseline to 24 months]
  • Improvement of Eating behaviors (Food Craving State Questionnaire) [Time frame: Baseline to 24 months]
  • Improvement of Eating behaviors (Food Craving Trait Questionnaire) [Time frame: Baseline to 24 months]
  • Decrease in food explicit and implicit wanting and liking food reward. [Time frame: Baseline to 24 month]
  • Improvement in well-being, mood and Quality of Life (SF-36) [Time frame: Baseline to 24 months]
  • Improvement in well-being, mood and Quality of Life (QLaval) [Time frame: Baseline to 24 months]
  • Improvement in well-being, mood and Quality of Life (HAD questionnaire) [Time frame: Baseline to 24 months]
  • Gastro-intestinal side-effects [Time frame: Baseline to 24-month]
  • Improvement of Eating behaviors (Binge Eating Scale) [Time frame: Baseline to 24 months]
  • Improvement of Eating behaviors (YFAS 2.0) [Time frame: Baseline to 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Criucpq-Ul — Québec

Identifiers

NCT: NCT06620562 · Sleeve-Plus

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗