Recruiting

Naltrexone-Bupropion

Sponsor:

Laval University

Code:

NCT06620562

Conditions

Obesity; Drug

Obesity, Morbid

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Naltrexone/Bupropion

Placebo

Study Details

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

Study ID

NCT06620562

Start date

Jun 4, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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

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 measure

  • Weight loss [ Time Frame: baseline to 24 months ]
  • Percentage of participant with an Excess Weight Loss above 50% [ Time Frame: Baseline to 24 months ]

Central Contacts and Locations

Central contacts

Mélanie Nadeau

4186568711melanie.nadeau@criucpq.ulaval.ca

Locations

Criucpq-Ul

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Mélanie Nadeau

4186568711melanie.nadeau@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-08-08.