Effects of Nabilone on Brain Enzyme Levels in Healthy Individuals
Investigating the Effects of Nabilone on Endocannabinoid Metabolism in the Human Brain
This study is testing if the drug nabilone can lower certain brain enzyme levels in healthy people and how that might affect their mood.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05885685 on ClinicalTrials.gov |
What this trial studies
This study investigates how nabilone, a synthetic cannabinoid, affects the levels of the endocannabinoid enzyme fatty acid amide hydrolase (FAAH) in the brains of healthy participants. Using advanced imaging techniques like MRI and PET, the study aims to determine if nabilone decreases FAAH levels and whether these changes correlate with clinical responses to the drug. Participants will undergo a series of assessments, including brain scans and mood evaluations, while receiving a one-week course of nabilone. The study will involve 30 healthy individuals who will be closely monitored throughout the process.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 19-65 who can tolerate the nabilone dosing regimen.
Not a fit: Patients with serious medical conditions, psychiatric disorders, or recent drug use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of cannabinoid effects on the brain, potentially leading to improved treatments for conditions related to the endocannabinoid system.
How similar studies have performed: While there is limited data on the specific effects of nabilone on FAAH levels, other studies have explored cannabinoid impacts on the endocannabinoid system, indicating potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 19-65 years old. For safety reasons, we will ask participants to provide photo ID showing birthdate, in order to verify age. * The ability to tolerate complete dosing regimen of nabilone (2mg titrated, 1 week course) * Able to sign and date informed consent form. * Willing and able to complete study as described in protocol Exclusion Criteria: * Serious, unstable medical condition including but not limited to cerebrovascular, renal, hepatic and coronary heart disease; * Coagulation/Blood Disorders or use of anticoagulant medication * Past or current neurological illness or head trauma; * Lifetime diagnosis of DSM-5 Axis I psychiatric conditions including mood, anxiety, eating, somatoform and/or psychotic disorders and substance abuse and/or dependence; * Suicidality or history of suicide attempts; * Family history of psychotic disorders (first degree relative with a psychotic disorder); * Current use (\~30 days) of drugs of abuse that may affect the CNS, including cannabis; * Tobacco dependence (Fagerstrom Test for Nicotine Dependence \>4); * Pregnancy or breastfeeding; * Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning; * Claustrophobia; * Known sensitivity to marijuana or other cannabinoid agents; * Are on medications known to interact with nabilone such as: diazepam, sodium secobarbital, alcohol, codeine, any medications that affect mental and/or psychomotor function; * Positive during drug screening for drugs of abuse; * Exposure to radiation \<20 mSv in the last 12 months and a number of PET scans that, including the number of PET scans under this protocol, will bring the total to more than 8 PET scans/lifetime, exceeding permissible limit for subjects participating in research set by Brain Health Imaging Centre Guideline; * Participant has any other problem that, in the investigators opinion, would preclude participation in the trial;
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Isabelle Boileau, PhD — Centre for Addiction and Mental Health
- Study coordinator: Raesham Mahmood, BSc
- Email: Raesham.Mahmood@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.