Obesity; Drug, Obesity, Morbid
Conditions
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Bausch Health Canada
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a single-center double-blind randomized placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | baseline to 24 months | % Excess weight loss |
| Percentage of participant with an Excess Weight Loss above 50% | Baseline to 24 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Eating behaviors (Food Craving State Questionnaire) | Baseline to 24 months | Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome. |
| Improvement of Eating behaviors (Food Craving Trait Questionnaire) | Baseline to 24 months | Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome. |
| Decrease in food explicit and implicit wanting and liking food reward. | 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 |
| Improvement in well-being, mood and Quality of Life (SF-36) | 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 |
| Improvement of Eating behaviors (Binge Eating Scale) | 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. |
| Improvement in well-being, mood and Quality of Life (HAD questionnaire) | 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 |
| Gastro-intestinal side-effects | 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 |
| Improvement of Eating behaviors (YFAS 2.0) | 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). |
| Improvement in well-being, mood and Quality of Life (QLaval) | 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 |
| Resolution of associated comorbidities | Baseline to 24 months | Type 2 diabetes, hypertension and dislipidemia |
Countries
Canada
Contacts
Primary ContactMélanie Nadeau
Outcome results
None listed