Investigating the Effects of Nabilone on Endocannabinoid Metabolism

NCT05885685 | Completed Phase 4

• 2 other identifiers: 098-2017CAMHPET-CTA-109
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Healthy

Keywords

nabilone; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• [11C]CURB binding in the brain

  Change in levels of \[11C\]CURB binding in the brain as indicated by the lambda k3 value from baseline to post-nabilone

  4 weeks

Secondary Outcomes (4)

• [11C]CURB decreases related to mood related assessments

  4 weeks

• [11C]CURB decreases related to drug-related effects

  4 weeks

• [11C]CURB decreases related to drug-related effects

  1 week

• [11C]CURB related to blood measurements of endocannabinoids

  4 weeks

Study Arms (1)

Healthy Participants

EXPERIMENTAL

Participants will be prescribed a 1 week daily oral dose of nabilone which will begin at 0.25 mg and work their way up to 2 mg over the course of 7 days.

Drug: Nabilone Oral Capsule

Interventions

Nabilone Oral Capsule DRUG

Each oral capsule contains a 0.25 mg dose of nabilone. Participants begin by taking 1 capsule at night then 1 capsule in the morning and 1 at night for the next 2 days. On the 4th day, the dose is doubled. On the 6th day, the dose is doubled again.

Also known as: TEVA-nabilone

Healthy Participants

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Interventions

nabilone

Study Officials

• Isabelle Boileau, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Stefan Kloiber, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: October 31, 2023
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: March 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: June 2023 - indefinitely

Locations

CA (1)