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HealthyPhase 4NABINCT05885685

Investigating the Effects of Nabilone on Endocannabinoid Metabolism

A Phase 4 study testing Nabilone Oral Capsule in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nabilone Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
31 Oct 2023to 5 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
Show all 16Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Investigating the Effects of Nabilone on Endocannabinoid Metabolism in the Human Brain

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)
Read the detailed description

There is limited data regarding the effect of exogenous cannabinoids, such as tetrahydrocannabinol (THC), on the endogenous cannabinoid system (eCS). Specifically, we do not know whether brain levels of fatty acid amide hydrolase (FAAH), the catabolic enzyme for the endocannabinoid anandamide, is affected by sub-chronic THC exposure.

Our primary objective is to use positron emission tomography (PET) imaging of the FAAH probe [11C]CURB to test the hypothesis that exposure to nabilone, a synthetic THC analogue, will reduce FAAH levels in the brain. Our secondary objective is to investigate whether reductions in FAAH levels are related to clinical response to nabilone.

Participant eligibility will be assessed through a series of questionnaires and assessments on medical, family, psychiatric and alcohol and drug use history. Individuals will also be required to provide blood and urine samples which we will test for recent drug use and pregnancy in female participants. Thirty healthy participants will complete one magnetic resonance imaging scan and two PET scans with [11C]CURB: one at baseline prior to nabilone administration and one approximately 4 weeks apart following a one week, 2 mg titrated dose of nabilone. Venous and arterial blood draws will be done during PET scans to measure FAAH genotype and plasma radiometabolites, respectively. Mood assessments will also be administered at these visits. During the nabilone dosing period, we will meet virtually with participants to check-in and monitor their tolerance and compliance.

Understanding whether recent nabilone exposure affects FAAH levels in brain may help to explain variability in clinical response to THC, the main psychoactive component in cannabis. This information can help guide therapeutic use of cannabis and cannabinoid derivatives, and aid in the development of evidence-based medicine targeting the eCS.

Conditions
Healthy
Being tested
Nabilone Oral Capsule
Keywords
nabilone, positron emission tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nabilone Oral CapsuleDrug

    Also called TEVA-nabilone

    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.

Study groups in NCT05885685
Study groupRoleWhat they receive
Healthy ParticipantsExperimentalParticipants 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.
Receives: Drug: Nabilone Oral Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (4)

  1. [11C]CURB decreases related to mood related assessments

    Changes in mood related assessment Profile of Mood States (POMS) scores from baseline to post-nabilone. Negative subscales include tension (9 items, range 0-36), depression (15 items, range 0-60), fatigue (7 items, 0-28), confusion (7 items, range 0-28), and anger (12 items, range 0-48). Positive subscale includes vigor (8 items, range 0-32).

    Measured: 4 weeks

  2. [11C]CURB decreases related to drug-related effects

    Changes in drug-related assessment Addiction Research Center Inventory (ARCI) scores from baseline to post-nabilone (81 items, range 0-81) with higher score indicating greater drug-related effects.

    Measured: 4 weeks

  3. [11C]CURB decreases related to drug-related effects

    Changes in drug-related assessment Visual Analogue Scales (VAS) score from beginning of nabilone administration period to end of nabilone administration period. Score can range from a minimum of 0 (no pain) to a maximum of 10 (pain as bad as it could possibly be).

    Measured: 1 week

  4. [11C]CURB related to blood measurements of endocannabinoids

    Changes in blood measurements of endocannabinoids such as anandamide post-nabilone administration from baseline to post-nabilone.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start31 Oct 2023
  3. Primary completion5 Dec 2025
  4. Study completion5 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885685
Sponsor's protocol ID
098-2017
Other IDs
CAMHPET-CTA-109
Acronym
NABI
Status last verified
Dec 2025
First submitted
23 May 2023
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share and/or re-use the information that was already collected for this study with other researchers at CAMH or elsewhere, so it can be used in other studies to answer new or different scientific questions. We do not know what this research may be yet, but we think it will be related to future research on mental illness. The results of these studies will not be shared with participants from this study. Participants will not directly benefit from these future studies, but it is hoped that the research may help other people in the future. Any personal information that could identify participants will be removed or coded before the data is shared.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nabilone Oral Capsule in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[11C]CURB binding in the brain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885685.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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