A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery
Sponsored by St. Joseph's Healthcare Hamilton
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
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:
- 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