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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
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.
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.
Criucpq-Ul
Québec, Quebec, Canada
RECRUITINGWeight loss
% Excess weight loss
Time frame: baseline to 24 months
Percentage of participant with an Excess Weight Loss above 50%
Time frame: Baseline to 24 months
Resolution of associated comorbidities
Type 2 diabetes, hypertension and dislipidemia
Time frame: Baseline to 24 months
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 months
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 months
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 month
Improvement in well-being, mood and Quality of Life (SF-36)
36-item short form survey evaluating quality of life on a scale from 0 to 100, higher scores indicate better quality of life
Time frame: Baseline to 24 months
Improvement in well-being, mood and Quality of Life (QLaval)
Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life
Time frame: Baseline to 24 months
Improvement in well-being, mood and Quality of Life (HAD questionnaire)
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
Time frame: Baseline to 24 months
Gastro-intestinal side-effects
Gastro-intestinal side-effects assessed by GIQLI questionnaire on a scale from 0 to 144. Higher scores indicate better quality of life
Time frame: Baseline to 24-month
Improvement of Eating behaviors (Binge Eating Scale)
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.
Time frame: Baseline to 24 months
Improvement of Eating behaviors (YFAS 2.0)
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).
Time frame: Baseline to 24 months
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