Phase 4 Obesity Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give written consent before any study procedures begin.
• People who have been referred to the LEAF clinic by their doctor, or who have referred themselves to the LEAF clinic for weight loss, and who the LEAF clinic team has determined are appropriate for their weight loss program.
• Adults between the ages of 18 and 64 (the trial welcomes people of all genders).
• People with a Body Mass Index (BMI) above 30 (a measure of body weight relative to height).
• People with normal vision or vision that is fully corrected with glasses or contact lenses, as the study involves looking at and responding to images on a screen.
• People who can understand and speak English, as all study instructions are provided in English.
• People who are able to follow the study procedures, including having a way to get to the study locations and no significant mobility limitations that would prevent participation.
• People who have access to a secure internet connection for virtual appointments with the LEAF clinic team.

Who may not be able to join:

• People who report severe depression, significant thoughts of suicide, or who have a history of bipolar disorder or psychosis.
• People currently taking antidepressants, thyroid medication, or any medication known to affect appetite or seizure threshold (for example, bupropion, tamoxifen, or thioridazine).
• People with uncontrolled high blood pressure.
• People with a history of heart defects or symptoms that suggest a heart condition (not including coronary artery disease).
• People who have diabetes.
• People with a current or past history of addiction or substance use disorder, including those who have recently stopped using alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
• People with a history of an eating disorder, including Binge Eating Disorder, Bulimia Nervosa, or Anorexia Nervosa.
• People with a history of glaucoma (a condition affecting the eyes).
• People with a personal or family history of seizure disorders.
• People currently taking MAO inhibitors (within the past 14 days), blood pressure medications called pressor agents, blood thinners (coumadin), anti-seizure medications, phenylbutazone, other products containing bupropion (such as Wellbutrin, Zyban, or Aplenzin), or certain other medications that interact with bupropion, such as ticlopidine or clopidogrel (confirm with trial site).
• People with a history of thyroid disease, or chronic liver or kidney disease.
• People who regularly use opioids, methadone, or buprenorphine.
• People who are currently pregnant, planning to become pregnant during the study, or who are currently breastfeeding (a pregnancy test will be conducted at the in-person screening session).
• People with a known allergy to any ingredient in CONTRAVE® (the study medication), including lactose.
• People with hereditary conditions affecting how the body processes galactose or lactose (such as lactase deficiency or glucose-galactose malabsorption).
• People currently using other weight loss medications such as liraglutide, semaglutide, or orlistat.
• People currently taking ADHD medications (such as Vyvanse or Concerta) that are known to affect metabolism.
• People with severe claustrophobia (fear of enclosed spaces), which would prevent participation in the brain scan (MRI) portion of the study.
• People who are unable to lie still inside a scanner for approximately 30 minutes.
• People who have metal in their body that cannot be removed and that could pose a safety risk during an MRI scan.
• People with a history of concussion involving loss of consciousness for more than 5 minutes.
• People with a major neurological condition such as epilepsy, stroke, or brain tumours, as these would affect how the brain scan results are interpreted.
• People whose body size means they cannot fit into the MRI scanner (this is checked using a practice scanner at the Brain Imaging Centre).
• People who test positive for illicit drugs or cannabis at screening (note: cannabis users may still be considered eligible if they are able to abstain from cannabis use for approximately two weeks before the baseline session and two weeks before the final assessment — confirm with trial site).
• People who are unable to avoid nicotine, tobacco, and caffeine for at least three hours before brain activity (EEG) recordings, as these substances affect the results.
• People who are unable to tolerate the initial test dose of CONTRAVE® (the study medication).

Important: Always verify eligibility with the trial site directly before applying.