Trial Evaluating Effectiveness of Contrave (Naltrexone HCl / Bupropion HCl) for Weight Maintenance in Adults With BMI ≥ 27 Kg/m2, After 6 Month Intensive Behavior Modification Program: Contrave Obesity Trials (COR) Weight Maintenance Study

COR Weight Maintenance Study

Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance. The purpose of this study is to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care (dietary and behaviour counselling) will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.

2021-02-01

2023-12-31

2023-12-31

Active (not recruiting)

Early phase I

89

Inclusion Criteria: * ≥ 18 years of age * Body Mass Index (BMI) of ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity * Completed 6 month BCoE behaviour modification program with meal replacements and achieved ≥ 5% weight loss since start of program * Able and willing to provide signed informed consent Exclusion Criteria: * Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry) * 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 * Lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial * 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 * Simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat) * Uncontrolled hypertension, severe hepatic impairment, end-stage renal 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) * 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 * A 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel - 2 arms during first 6 month phase (treatment and placebo control)\n\nCrossover - placebo control group crosses over to treatment arm during second 6 months of the study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Masking during first 6 month phase (treatment or placebo control).\n\nAll participants receive treatment (Contrave) during second 6 months.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 89, 'type': 'ACTUAL'}}

2023-08-03