A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery (COR-WR)

This is an interventional treatment trial for Obesity focused on measuring weight recidivism, weight regain, inadequate weight loss Read More

Inclusion Criteria:

• >=18 years of age
• prior primary roux en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) at a surgical Center of Excellence within the Ontario Bariatric Network (OBN)

• inadequate weight loss or significant weight regain based on the OBN criteria13, defined as one of the following:

  1. < 10% total body weight (TBW) loss at 6 months or;
  2. < 20% TBW loss at 12 months or;
  3. Weight regain of > 25% of weight loss.
• body Mass Index (BMI) of ≥ 30 Kg/m2 or ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
• able and willing to provide signed informed consent

Exclusion Criteria:

• pregnancy, planned pregnancy in the next 18 months and or breastfeeding
• does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
• revisional bariatric procedure or duodenal switch
• simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat) or meal replacement products (e.g. Optifast)
• uncontrolled hypertension, severe hepatic impairment, end-stage renal disease, end stage cardiac disease
• myocardial infarction or stroke within 6 months prior to consent
• renal impairment defined as eGFR < 60
• seizure disorder or a history of seizures or following conditions that may predispose subjects to risk of seizure: history of head trauma, arteriovenous malformation, central nervous system tumor or infection, or a metabolic disorder that in opinion of the investigator may contraindicate treatment with Contrave and increase risk of seizure (e.g. hypoglycemia, hyponatremia)
• lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
• history of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders
• use of other bupropion-containing products (including, but not limited to, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban), because the incidence of seizure is dose dependent
• current or prior diagnosis of bulimia or anorexia nervosa, because of a higher incidence of seizures
• chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opiate withdrawal
• excessive use of alcohol or sedatives, addiction to cocaine or stimulants (street drugs), or withdrawal from sedatives
• patients undergoing an abrupt discontinuation of alcohol, benzodiazepines or other sedatives and antiepileptic drugs
• concomitant administration of monoamine oxidase inhibitors (MAOI). At least 14 days should elapse between discontinuation of a MAOI and initiation of treatment with Contrave
• concomitant administration of the antipsychotic thioridazine, since bupropion may inhibit thioridazine metabolism, thus causing an increase in thioridazine levels and a potential increased risk of thioridazine-related serious ventricular arrythmias and sudden death
• known hypersensitivity (or known allergic reaction) to the investigational product(s) or any of its ingredients including lactose
• current participation in another interventional clinical trial
• not able to complete subject reported, self administered questionnaires or cannot fully understand all instructions in English