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Identifying the Short-Term Neurobiological, Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
Led by The Royal's Institute of Mental Health Research · Updated on 2025-07-24
40
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
The Royal's Institute of Mental Health Research
Lead Sponsor
U
University of Ottawa
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 64 with obesity to understand how the drug CONTRAVE40 affects weight loss mechanisms. This study compares CONTRAVE40 plus a diet program against a placebo plus the same diet program. The aim is to explore how CONTRAVE40 influences mood, body composition, metabolism, brain activity, appetite, cravings, and behavioral factors related to obesity. Participants will be randomly assigned to two groups: one receiving CONTRAVE40 and the other a placebo, both alongside a 4-week individualized diet program from a registered dietitian. The drug dose is gradually increased to a therapeutic level over four weeks. The study involves five in-person visits for screening, baseline testing, intervention, and follow-up. Participants will take their assigned pills twice daily and engage in weekly diet coaching. Daily online monitoring of medication adherence and side effects will occur during the intervention. Participants will complete assessments at baseline and after four weeks, including body composition, resting energy expenditure, food preferences, cognitive tests, brain scans (EEG and MRI), and questionnaires on mood and behavior. Safety and side effects will be regularly monitored. The study will measure changes in brain activity related to food impulsivity and reward, body weight and composition, and metabolic and mood effects. Total participation includes screening, baseline visits, a 4-week treatment period, and post-intervention testing.
CONDITIONS
Brief Title
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before starting study procedures
- Referred or self-referred to the LEAF clinic for weight loss and deemed appropriate for treatment
- Adults aged 18 to 64 years, all genders included
- Body mass index (BMI) greater than 30
- Normal or corrected vision
- Understand and speak English
- Able to follow the study protocol and travel to study locations
- Have access to a secure internet connection for virtual appointments
You will not qualify if you...
- Severe depression, significant suicidal thoughts, bipolar disorder, or psychosis
- Current use of antidepressants, thyroid medication, or drugs affecting appetite or seizure threshold
- Uncontrolled hypertension
- History of heart defects or related symptoms (excluding coronary artery disease)
- Diabetes
- Past or current substance use disorders or withdrawal
- History of eating disorders such as binge eating, bulimia, or anorexia
- History of glaucoma
- Personal or family history of seizures
- Use of MAO inhibitors, coumadin, anticonvulsants, or bupropion-containing products
- History of thyroid, liver, or kidney disease
- Chronic use of opioids or related medications
- Currently pregnant, planning pregnancy, or nursing
- Allergy to CONTRAVE40 ingredients
- Hereditary lactose or galactose intolerance
- Current use of obesity medications like liraglutide, semaglutide, or orlistat
- Use of ADHD medications impacting metabolism
- Severe claustrophobia or inability to lie still for MRI
- Metal implants unsafe for MRI
- History of significant concussion or major neurological illness
- Obesity too severe to fit in MRI scanner
- Positive drug test for illicit drugs or cannabis (with required abstinence periods)
- Unable to abstain from nicotine or caffeine 3 hours before EEG testing
- Intolerance to CONTRAVE40 test dose
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including screening and test dose administration
Duration - 1 to 2 weeks
Participants complete baseline assessments including metabolics, cognition, food craving, EEG, and MRI imaging before starting the intervention.
4 visits (in-person) at two laboratory locations
Duration - 4 weeks
Participants take CONTRAVE® or placebo medication daily and follow the LEAF diet program with daily monitoring of adherence and side effects.
Daily self-reporting and weekly check-ins for side effects
Duration - 1 week
Participants complete the same testing sessions as baseline to assess effects after the 4-week treatment period.
2 visits (in-person) at laboratory locations
Trial Site Locations
Total: 3 locations
1
LEAF Weight Managment Clinic
Ottawa, Ontario, Canada, K1J 9L3
Actively Recruiting
2
Behavioural and Metabolic Research Unit
Ottawa, Ontario, Canada, K1N 6N5
Actively Recruiting
3
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4
Actively Recruiting
Research Team
N
Natalia Jaworska, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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