Obesity study: Contrave vs Diet Program
Official title Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
ClinicalTrials.gov ID: NCT06809166
What this study is testing
What is Contrave?
An investigational oral medication being studied for the treatment of obesity. It is designed to combine naltrexone and bupropion to influence appetite and reward pathways.
Also referred to as Naltrexone/Bupropion.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how CONTRAVE affects mood, body composition, metabolism, and brain activity compared to a placebo when combined with a diet program.
- Who it's for
- Adults aged 18‑64 who have obesity and meet the study’s health criteria.
- What's involved
- Participants will take either CONTRAVE or a placebo pill, follow a 4‑week diet plan, attend two baseline visits for body, brain, and metabolic tests, and repeat those tests after 4 weeks. They will also fill out questionnaires and meet with a dietitian weekly.
- Time commitment
- The study lasts 4 weeks, with two initial testing visits and a final visit after 4 weeks, plus weekly dietitian check‑ins and online questionnaires.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures
- 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...
You likely can't join if
- section).
- Adults: aged 18-64 years of age (gender and sex will be noted; recruitment is all-gender inclusive).
- Have a BMI\>30.
- Have normal or corrected vision as some of the study aspects will involve viewing/responding to visual stimuli.
- Understand and speak English (as instructions for study criteria will be provided in English).
- 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...
See the full eligibility criteria
- Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures
- 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...
- section).
- Adults: aged 18-64 years of age (gender and sex will be noted; recruitment is all-gender inclusive).
- Have a BMI\>30.
- Have normal or corrected vision as some of the study aspects will involve viewing/responding to visual stimuli.
- Understand and speak English (as instructions for study criteria will be provided in English).
- 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).
- Reporting severe depression or reporting significant suicidal ideation, or history of bipolar disorder or psychosis (i.e., major psychiatric condition
- Current use of antidepressants, thyroid medication, or any medication that could affect appetite, or seizure threshold (e.g.., bupropion, tamoxifen, thioridazine).
- Uncontrolled hypertension.
- History of cardiac defects or symptoms suggestive of any cardiac condition (not including coronary artery disease).
- Presence of diabetes.
- Current or past history of addictions or substance use disorder, including undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
- History of eating disorder (including Binge Eating Disorder, Bulimia Nervosa or Anorexia Nervosa).
- History of glaucoma.
- Personal or family history of seizure disorders.
- 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...
- History of thyroid disease, chronic liver, or renal disease.
- Chronic use of opioid, opiate agonist (Methadone) or partial agonists (Buprenorphine).
- 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.\ \ \
- No known allergy to any of the ingredients in CONTRAVE® (e.g. lactose).
- Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Current use of obesity medications such as liraglutide or semaglutide or orlistat.
- Severe claustrophobia.
- Inability to lie still in the scanner for approximately 30min.
- Metal in the body that cannot be removed and might pose a safety risk to the participant.
- History of concussion (loss of consciousness for \>5-min).
- Major neurological illness, such as, epilepsy, stroke, tumours (as this would interfere with the interpretation of the MRI data).
- 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.
- 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]).
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.