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NCT Number: NCT06620562

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

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.

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Key information

Conditions

Obesity; Drug Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Criucpq-Ul

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Mélanie Nadeau

CONTACT

[email protected]

4186568711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone/Bupropion

Drug

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

Drug

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 outcomes

  1. Weight loss

    Time frame: baseline to 24 months

    % Excess weight loss

  2. Percentage of participant with an Excess Weight Loss above 50%

    Time frame: Baseline to 24 months

Secondary outcomes

  1. Resolution of associated comorbidities

    Time frame: Baseline to 24 months

    Type 2 diabetes, hypertension and dislipidemia

  2. Improvement of Eating behaviors (Food Craving State Questionnaire)

    Time frame: Baseline to 24 months

    Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome.

  3. Improvement of Eating behaviors (Food Craving Trait Questionnaire)

    Time frame: Baseline to 24 months

    Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome.

  4. Decrease in food explicit and implicit wanting and liking food reward.

    Time frame: Baseline to 24 month

    Decrease in food explicit and implicit wanting and liking food reward assessed by Leeds Food Preference Questionnaire using a computerized behavioural task

  5. Improvement in well-being, mood and Quality of Life (SF-36)

    Time frame: Baseline to 24 months

    36-item short form survey evaluating quality of life on a scale from 0 to 100, higher scores indicate better quality of life

  6. Improvement in well-being, mood and Quality of Life (QLaval)

    Time frame: Baseline to 24 months

    Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life

  7. Improvement in well-being, mood and Quality of Life (HAD questionnaire)

    Time frame: Baseline to 24 months

    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

  8. Gastro-intestinal side-effects

    Time frame: Baseline to 24-month

    Gastro-intestinal side-effects assessed by GIQLI questionnaire on a scale from 0 to 144. Higher scores indicate better quality of life

  9. Improvement of Eating behaviors (Binge Eating Scale)

    Time frame: Baseline to 24 months

    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.

  10. Improvement of Eating behaviors (YFAS 2.0)

    Time frame: Baseline to 24 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mélanie Nadeau

CONTACT

[email protected]

4186568711

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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