A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery

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