40
Participants
Start Date
July 4, 2024
Primary Completion Date
January 1, 2026
Study Completion Date
July 31, 2026
Contrave
"CONTRAVE® will be titrated up to a therapeutic dose (Naltrexone 32mg/Bupropion 360mg) over a 4-week period as per clinical guidelines, and what is typical in the LEAF clinic. Dose recommendation for CONTRAVE® is tablet based, with each tablet containing 8mg of naltrexone and 90mg of bupropion. The maximum recommended daily dose is two tablets, administered orally, twice daily (32mg/360mg), taken once in the morning and once in the evening. Tablets and dispensing schedule will be done under the oversight of The Royal pharmacy (i.e., they will instruct the participants on the dosing schedule).~Medication adherence and side effects will be reported daily using our online data capture system (REDCap) (approximately 1min) starting on the evening of the first dose of administration. If adverse events are significantly concerning, there is a mechanism in place for dealing with such events."
Placebo
"Placebo intervention will follow the exact same protocol in terms of tablet numbers as the CONTRAVE intervention.~Generic Placebo pills will be packaged by The Royal Pharmacy into blister packs identical to Contrave."
Diet Program
All participants will receive an individualized dietary intervention with appropriate energy restriction from registered dietitians at Dr. Shiau's LEAF weight management clinic (called the 4-week BUDS program, which is offered to clients with obesity at the LEAF clinic). The program involves weekly touch points with a registered dietitian, and meal planning/coaching and integrates a partial meal replacement with a commercial shake.
RECRUITING
LEAF Weight Managment Clinic, Ottawa
RECRUITING
Behavioural and Metabolic Research Unit, Ottawa
RECRUITING
University of Ottawa Institute of Mental Health Research, Ottawa
Collaborators (1)
University of Ottawa
OTHER
The Royal Ottawa Mental Health Centre
OTHER
Bausch Health, Canada Inc.
UNKNOWN
Cheo Research Institute
OTHER
LEAF Weight Management Clinic
UNKNOWN
The Royal's Institute of Mental Health Research
OTHER