NCT06809166 Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 40 participants in total. It began in 2024-07-04 with a primary completion date of 2026-01-01.

Brief Summary

Obesity is a common chronic disease linked with increased risk for other illnesses and earlier death. Our team and others have shown that many bodily and psychological changes occur when individuals are on calorie-restricted diets. These changes might undermine dietary adherence and help to explain the relatively poor long-term efficacy of diets. These include increased appetite, increased food 'value' and 'wanting' that leads to overconsumption. Other factors include more sensitive sensory cues (e.g., smelling), higher food liking and craving, and a drop in resting energy expenditure (REE). REE has been shown to predict weight regain. The standard care for obesity may include the use of the weight-loss drug CONTRAVE®. The Federal Drug Agency (FDA) and Health Canada have approved this drug for weight management and obesity treatment. Although CONTRAVE® was designed to reduce appetite, food-related impulsivity and cravings, its mechanisms of action are unclear. In other words, the effects of CONTRAVE® on REE, executive function, and brain changes remain unknown in humans. A better understanding of how this drug works on the brain and body could lead to improvements in obesity management in the future. As such, the goal of this research is to study the effects of 4 weeks of CONTRAVE® (+ diet program) vs. control (placebo pill + diet program) on mood, body composition changes, biological/metabolic measures, and brain measures. Adults aged 18-64 with obesity will be randomized to one of two groups: diet + CONTRAVE® (CONTRAVE®, 20 participants) or diet + Placebo (Placebo, 20 participants). Both groups will be assigned the same study procedures for the entire study duration. The only difference is that Group 1 will receive CONTRAVE® while Group 2 will receive a placebo (non-medical) pill. The study design and intervention is as follows: Participants who meet all the telephone screening criteria will be invited to the Clinical EEG \& Neuroimaging Laboratory at The Royal's IMHR for an in-person screening and test-dose session. Participants who are cleared by the study physician, Dr. Pierre Blier, during the in-person screening will be enrolled in the 4-weeks trial. After the in-person screening visit, participants will attend two baseline testing visits (before starting the medication + diet program). The first will occur at the Behavioural and Metabolic Research Unit at the University of Ottawa. During this in-person visit, measures of body composition, resting energy expenditure, appetite, food craving, impulsivity, eating behaviours, taste and odour sensitivity, energy intake, and food preference will be collected. The second baseline visit (within a week of the first one) will occur at The Royal/IMHR. During this visit, participants will be asked to complete questionnaires. They will undergo an EEG recording while resting and performing computer tasks. They will also get a brain imaging scan, during which they are asked to rest and complete a computer task. Both testing sessions (University of Ottawa and Royal Ottawa testing sessions) will be repeated after four weeks of treatment. The section below provides further description and timing of these visits. As part of the treatment, you will receive an individualized dietary intervention with appropriate energy restriction from a registered dietitian at Dr. Judy Shiau's LEAF weight management clinic (called the 4-week BUDS program). The program involves weekly touch points with a registered dietitian and meal planning/coaching. The diet intervention will commence the same week as the start of the placebo/CONTRAVE®. During the 4-week intervention, participants will be asked to complete online questionnaires at various times.

Eligibility Criteria

Inclusion Criteria: 1. Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures 2. Have been referred to the LEAF clinic by their physician or have self-referred to the LEAF clinic for weight loss, and have been deemed appropriate for weight loss treatment offered by the LEAF clinic (i.e., these criteria are at the discretion of the clinical team at the LEAF clinic, outlined below in the exclusion criteria section). 3. Adults: aged 18-64 years of age (gender and sex will be noted; recruitment is all-gender inclusive). 4. Have a BMI\>30. 5. Have normal or corrected vision as some of the study aspects will involve viewing/responding to visual stimuli. 6. Understand and speak English (as instructions for study criteria will be provided in English). 7. Able to participate in the study protocol as described, e.g. have a means of getting to the laboratories and no major mobility issues to the extent that protocols cannot be followed (details below). 8. Access to a secure internet connection (for virtual appointments with members of the LEAF clinic). Exclusion Criteria: 1. Reporting severe depression or reporting significant suicidal ideation, or history of bipolar disorder or psychosis (i.e., major psychiatric condition; this will be ascertained during the screening carried out by research personnel, in keeping with our standard protocols in Dr. Jaworska's laboratory).\*\*\* 2. Current use of antidepressants, thyroid medication, or any medication that could affect appetite, or seizure threshold (e.g.., bupropion, tamoxifen, thioridazine). 3. Uncontrolled hypertension. 4. History of cardiac defects or symptoms suggestive of any cardiac condition (not including coronary artery disease). 5. Presence of diabetes. 6. Current or past history of addictions or substance use disorder, including undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. 7. History of eating disorder (including Binge Eating Disorder, Bulimia Nervosa or Anorexia Nervosa). 8. History of glaucoma. 9. Personal or family history of seizure disorders. 10. Currently taking MAO inhibitors (within 14 days), pressor agents, coumadin, anticonvulsants, or phenylbutazone, or other bupropion-containing products (such as Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin or Zyban), or CYP2B6 inhibitors (e.g. ticlopidine or clopidogrel). 11. History of thyroid disease, chronic liver, or renal disease. 12. Chronic use of opioid, opiate agonist (Methadone) or partial agonists (Buprenorphine). 13. Currently pregnant or planning to become pregnant during the intervention or currently nursing. Pregnancy urine test will be conducted during the in-person screening session in the laboratory.\*\*\* 14. No known allergy to any of the ingredients in CONTRAVE® (e.g. lactose). 15. Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. 16. Current use of obesity medications such as liraglutide or semaglutide or orlistat. 17. Current use of medication indicated in patient living with ADHD (e.g., Vivanse/Concerta) which are known to have metabolic impacts. There are several additional exclusionary criteria, established by research personnel in Dr. Jaworska's laboratory (i.e., not part of LEAF intake) that preclude participation in the brain imaging/magnetic resonance imaging (MRI) and EEG, these include: 18. Severe claustrophobia. 19. Inability to lie still in the scanner for approximately 30min. 20. Metal in the body that cannot be removed and might pose a safety risk to the participant. 21. History of concussion (loss of consciousness for \>5-min). 22. Major neurological illness, such as, epilepsy, stroke, tumours (as this would interfere with the interpretation of the MRI data). 23. Obesity to the extent that the participant cannot fit into the scanner. This will be established by ensuring that the individual can fit into the mock scanner at the Brain Imaging Centre (BIC) of The Royal. If a person cannot fit into the mock scanner, it is unlikely that the person can fit into the real scanner. 24. Testing positive for illicit drugs and cannabis (this will be established using a drug test that will be administered in the Clinical EEG \& Neuroimaging laboratory at the Institute of Mental Health Research \[IMHR\]). Participants who are cannabis users will be invited to participate in the study so long as they can abstain from cannabis use for approximately 2weeks prior to the baseline session and approximately 2weeks before final assessment. Ideally, participants would also abstain from cannabis use during treatment, but, this will not be tested/enforced. 25. Ability to abstain from nicotine/tobacco and caffeine for 3h prior to the baseline testing/EEG recordings, as both substances influence EEG activity. NOTE: If a participant cannot participate in the MRI aspect of the study (i.e., due to the above exclusion criteria), they will still be able to participate in the research study (apart from the MRI component). All MRI/EEG exclusion criteria will be established during the screening/clinical interview carried out by trained research staff from Dr. Jaworska's laboratory (details below). One final exclusion criterion is as follows: 26. Unable to tolerate the test dose of CONTRAVE® (details below). Such individuals would not participate in further elements of the research, but, would continue with their treatment through the LEAF clinic (as determined by the LEAF clinic, per their clinical management program).

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