Investigating the Effects of Nabilone on Endocannabinoid Metabolism

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · May 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called nabilone, which is similar to compounds found in cannabis, to see how it affects certain enzymes in the brain of healthy individuals. Specifically, researchers want to find out if nabilone reduces the levels of an enzyme called FAAH, which is involved in breaking down natural substances in the body that are similar to cannabis. To do this, participants will undergo brain scans and take nabilone for one week while the researchers monitor any changes.

To participate in this study, you must be between 19 and 65 years old and be in good health, meaning you don’t have serious medical conditions or a history of certain psychiatric disorders. Participants will have an initial interview lasting about four hours, two brain imaging sessions that will take about eleven hours total, and virtual check-ins to discuss their experience with nabilone. It’s important to know that this trial is still looking for volunteers, and if you decide to participate, you'll need to agree to follow the study guidelines closely.

Gender

ALL

Eligibility 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;