NCT06595576

Cannabis Edibles and Simulated Driving

Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this human laboratory experiment is to determine the acute and residual effects of a range of doses of orally administered cannabis edibles on driving simulator performance in people who use cannabis recreationally. Four conditions will be tested: placebo, low dose, medium dose and high dose. Driving performance will be tested objectively using a driving simulator during a number of pre-programmed driving scenarios. The investigators will test the hypothesis that driving performance on a high-fidelity driving simulator will decrease with increasing doses of cannabis. Secondary objectives will: * Determine the acute and residual (24 hour) cognitive, behavioural, and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects, cognitive tests, verbal memory, and mood. * Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance, as well as cognitive, behavioural, and physiological measures. Cannabinoid levels in blood, urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure. The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame. * Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following: circulating cell-free mtDNA (ccf-mtDNA), endocannabinoids, and metabolic biomarkers.

Conditions

• Cannabis
• Driving Under the Influence

Interventions

Type	Name	Description
DRUG	Cannabis - Placebo Dose (0 mg)	Participants will consume placebo cannabis edibles.
DRUG	Cannabis - Low Dose (2 mg)	Participants will consume a low dose (2 mg) of cannabis edibles.
DRUG	Cannabis - Medium Dose (10 mg)	Participants will consume a medium dose (10 mg) of cannabis edibles.
DRUG	Cannabis - High Dose (20 mg)	Participants will consume a high dose (20 mg) of cannabis edibles.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2024-09-19
• Last updated: 2025-08-03

Locations

1 site across 1 country: Canada