Trial intelligence / Profile preview

Effects of Nabilone on Endocannabinoid Metabolism in Healthy Brains

NCT05885685Phase 4

Key facts

Status: Completed
Start: Oct 2023
Primary completion: Dec 2025
Countries: 1
Sponsor: Center for Addiction and Mental Health
Modality: Small Molecules

Drugs: nabilone

Overview

Phase 4, open-label, single-arm trial of nabilone, sponsored by Center for Addiction and Mental Health. Primary endpoint: [11C]CURB binding in the brain at 4 weeks. Started Oct 2023; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Healthy Participants
Participants receive a 1-week titrated dose of nabilone (up to 2 mg) and undergo baseline and follow-up PET/MRI scans.

Who it enrols

Healthy volunteers aged 19-65 without psychiatric, neurological, or serious medical conditions, and no recent drug abuse or use of interacting medications.

Endpoints

Primary

[11C]CURB binding in the brain4 weeks

Secondary

[11C]CURB decreases related to mood related assessments4 weeks
[11C]CURB decreases related to drug-related effects4 weeks
[11C]CURB related to blood measurements of endocannabinoids4 weeks

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