Nabilone for Healthy Individuals

(NABI Trial)

Overseen By Isabelle Boileau, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticoagulants, Diazepam, Alcohol, Codeine

Disqualifiers: Neurological illness, Psychiatric conditions, Tobacco dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interact with nabilone, such as diazepam, sodium secobarbital, alcohol, codeine, or any medications that affect mental or physical function. The trial does not specify a washout period, but it's important to discuss your current medications with the study team.

What is the purpose of this trial?

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)

Research Team

Stefan Kloiber, MD

Principal Investigator

Centre for Addiction and Mental Health

Isabelle Boileau, PhD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for healthy adults aged 19-65 who can handle a week-long course of nabilone, a cannabis-like substance. Participants must be able to provide ID for age verification, sign informed consent, and commit to completing the study activities including interviews and brain scans.

Inclusion Criteria

I am between 19 and 65 years old.

I can handle the full dose of nabilone for a week.

I can sign and understand the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Participants undergo baseline MRI and PET scans to assess initial FAAH levels

1 day

1 visit (in-person)

Treatment

Participants receive a 1-week titrated dose of nabilone, starting at 0.25 mg and increasing to 2 mg

1 week

Virtual check-ins

Post-Treatment Imaging

Participants undergo follow-up PET scans to assess changes in FAAH levels after nabilone treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mood and drug-related assessments

4 weeks

Treatment Details

Interventions

• Nabilone

Trial Overview The study tests how nabilone affects an enzyme in the brain related to endocannabinoids using MRI and PET scans. It aims to determine if nabilone lowers this enzyme's levels and if such changes correlate with how participants respond clinically to the drug.

Participant Groups

Group I: Healthy Participants Experimental Treatment 1 Intervention

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.

Nabilone is already approved in United States, Canada, United Kingdom for the following indications:

Approved in United States as Cesamet for:

• Chemotherapy-induced nausea and vomiting

Approved in Canada as Cesamet for:

• Chemotherapy-induced nausea and vomiting

Approved in United Kingdom as Cesamet for:

• Chemotherapy-induced nausea and vomiting

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+