Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 4, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

July 31, 2026

Conditions
ObesityWeight LossWeight ManagementDietary InterventionObesity/Therapy
Interventions
DRUG

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."

DRUG

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."

BEHAVIORAL

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.

Trial Locations (3)

K1J 9L3

RECRUITING

LEAF Weight Managment Clinic, Ottawa

K1N 6N5

RECRUITING

Behavioural and Metabolic Research Unit, Ottawa

K1Z 7K4

RECRUITING

University of Ottawa Institute of Mental Health Research, Ottawa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Ottawa

OTHER

collaborator

The Royal Ottawa Mental Health Centre

OTHER

collaborator

Bausch Health, Canada Inc.

UNKNOWN

collaborator

Cheo Research Institute

OTHER

collaborator

LEAF Weight Management Clinic

UNKNOWN

lead

The Royal's Institute of Mental Health Research

OTHER