Investigating the Effects of Nabilone on Endocannabinoid Metabolism

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn about the effects of a cannabis-like substance, nabilone, on the levels of endocannabinoid enzyme fatty acid amide hydrolase (FAAH) in brain of healthy individuals. Using magnetic resonance imagine (MRI) and positron emission tomography (PET), the main questions we aim to answer are: 1) Does nabilone decrease levels of FAAH in the brain? and 2) Are changes in levels of FAAH associated with clinical response to nabilone? Participants will complete:

• An in-person interview (~4 hours)

• Two brain imaging scanning sessions (~11 hours)

• A one week 2 mg titrated dose of nabilone

• Virtual check-ins (up to ~1.5 hours)

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Nabilone

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;