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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests nabilone, a substance similar to cannabis, to observe its effects on a brain enzyme called FAAH. Researchers will use brain scans to determine if nabilone alters FAAH levels and whether these changes relate to treatment response. The study seeks healthy individuals who can complete a week-long course of nabilone, gradually increasing to a 2mg dose. Participants should not have serious medical conditions or a history of mental health issues. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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 safety track record for nabilone?

Research has shown that nabilone has been tested and used to treat nausea and vomiting in cancer patients, indicating it is generally well-tolerated in humans. Some people may feel sleepy or lightheaded, as reports show that drowsiness or dizziness can occur.

Nabilone is a Schedule II drug, meaning it carries a risk of dependency or abuse, so it should be used carefully. Mixing nabilone with alcohol or other substances that affect the mind can lead to unwanted effects.

People with severe liver problems or certain emotional disorders should exercise extra caution. Overall, nabilone has a history of safe use, but awareness of these potential side effects is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Nabilone is unique because it is a synthetic cannabinoid that mimics the effects of THC, the active compound in cannabis. Unlike traditional treatments that might not target the same pathways, Nabilone interacts with the body's endocannabinoid system, potentially offering different benefits. Researchers are excited about its potential to provide relief with fewer side effects compared to some conventional medications. Additionally, its ability to be carefully dosed over a short period allows researchers to quickly assess its impact on patients, setting it apart from treatments that might take longer to evaluate.

What is the effectiveness track record for nabilone?

Research has shown that nabilone, a substance similar to cannabis, may help with several conditions. For people with posttraumatic stress disorder (PTSD), nabilone helps them sleep longer and reduces nightmares. It has also been somewhat effective in treating long-term pain and nausea. In another study, nabilone improved headaches and the quality of life for people who overuse headache medication. While results can differ, nabilone shows promise in these areas. This trial will investigate how nabilone might affect brain enzyme levels in healthy individuals. ^{6 7 8 9 10}

Who Is on the Research Team?

Isabelle Boileau, PhD

Principal Investigator

Centre for Addiction and Mental Health

Stefan Kloiber, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538943/

Nabilone for Chronic Pain Management: A Review of ... - NCBI Mixed results from two RCTS of FMS patients, one reported nabilone led to pain relief (n=40) and the other reported nabilone did not reduce ...

2. nature.com nature.com/articles/s41531-024-00665-7

Long-term safety and efficacy of open-label nabilone on ... Clinical trial data from other cohorts suggests that nabilone improves nightmares and sleep duration in posttraumatic stress disorder as well as ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3484259/

Nabilone for the treatment of medication overuse headache This is the first randomized controlled trial demonstrating the benefits of nabilone on headache, analgesic consumption and the quality of life in patients ...

4. sciencedirect.com sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/nabilone

Nabilone - an overview | ScienceDirect Topics Laboratory studies and clinical reports suggest that nabilone has moderate efficacy in the treatment of nausea, chronic pain, pain-associated insomnia, PTSD- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02351882

Safety and Efficacy of Nabilone in Alzheimer's Disease Nabilone is a new class of medication that may be a safe and effective treatment for agitation in AD, with added benefits on appetite and pain. Reducing these ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/018677Orig1s017lbl.pdf

Cesamet® (nabilone) Capsules DESCRIPTION Cesamet was evaluated for its effectiveness and safety in the treatment of nausea and vomiting induced by cancer chemotherapy in patients receiving a wide ...

7. sigmaaldrich.com sigmaaldrich.com/US/en/sds/sigma/n3785?srsltid=AfmBOoq7SyQAkacgiUFWuYYBXWhsiS-HTOlKXIhEC1LUfSmYSNdSJh3P

• SAFETY DATA SHEET May cause drowsiness or dizziness. Specific target organ toxicity - repeated exposure. No data available. Aspiration hazard. No data available ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK547865/

Nabilone - LiverTox - NCBI Bookshelf - NIH Nabilone is classified as a Schedule II drug, indicating that it has clear potential for physical and psychological dependency and abuse.

9. pdf.hres.ca pdf.hres.ca/dpd_pm/00026247.PDF

N ACT NABILONE ACT NABILONE should not be taken with alcohol, sedatives, hypnotics, or other psychotomimetic substances. ACT NABILONE should not be used ...

10. dhpp.hpfb-dgpsa.ca dhpp.hpfb-dgpsa.ca/dhpp/resource/87881/consumer-information

Consumer Information for: ACT NABILONE ACT NABILONE should be used with extreme caution if you have severe liver dysfunction or a history of nonpsychotic emotional disorders.