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Cannabinoid

Healthy Participants for Healthy Subjects (NABI Trial)

Phase 4

Recruiting

Led By Stefan Kloiber, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

NABI Trial Summary

This trial aims to study the effects of a cannabis-like substance called nabilone on a specific enzyme in the brain of healthy individuals. The study will use brain imaging techniques to answer two main questions:

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of nabilone may include dizziness, dry mouth, sleepiness or an elevated mood. The exact side effects will be monitored through virtual check-ins.

NABI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[11C]CURB binding in the brain

Secondary outcome measures

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

[11C]CURB decreases related to mood related assessments

[11C]CURB related to blood measurements of endocannabinoids

NABI Trial Design

1Treatment groups

Experimental Treatment

Group I: Healthy ParticipantsExperimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,428 Total Patients Enrolled

Stefan Kloiber, MDPrincipal InvestigatorCentre for Addiction and Mental Health

Isabelle Boileau, PhDPrincipal InvestigatorCentre for Addiction and Mental Health

2 Previous Clinical Trials

23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants in this medical study at the moment?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively pursuing potential participants. The trial was initially posted on October 31st, 2023 and last revised on February 16th, 2024. Currently, recruitment aims to enlist a total of 30 patients at one designated site."

Answered by AI

Is the clinical study open to participants who are below 65 years of age?

"Individuals aged between 19 and 65 are sought after for this trial, with a separate focus on pediatric patients under 18 years old and elderly individuals over the age of 65 across numerous clinical trials."

Answered by AI

What is the current number of participants being admitted into this research trial?

"Affirmative. The information available on clinicaltrials.gov confirms that this particular research study is presently in search of suitable participants. Initially shared on October 31st, 2023, and subsequently updated on February 16th, 2024, the trial aims to recruit a total of 30 individuals from one designated site."

Answered by AI

What are the safety implications of involving individuals without medical conditions in research studies?

"According to our team at Power, Healthy Participants are rated a 3 for safety on the scale of 1 to 3 due to this being a Phase 4 trial denoting approval of treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Effects of Nabilone on Endocannabinoid Metabolism

2023. "Investigating the Effects of Nabilone on Endocannabinoid Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05885685.