Cannabis Edibles and Simulated Driving

NCT ID: NCT06595576

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-04-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo Cannabis Edibles (0 mg THC)

Participants consume a placebo dose of cannabis edibles (0 mg THC).

Group Type: EXPERIMENTAL

Cannabis - Placebo Dose (0 mg)

Intervention Type: DRUG

Participants will consume placebo cannabis edibles.

Low Dose Cannabis Edibles (2 mg THC)

Participants consume a low dose of cannabis edibles (2 mg THC).

Group Type: EXPERIMENTAL

Cannabis - Low Dose (2 mg)

Intervention Type: DRUG

Participants will consume a low dose (2 mg) of cannabis edibles.

Medium Dose Cannabis Edibles (10 mg)

Participants consume a medium dose of cannabis edibles (10 mg THC).

Group Type: EXPERIMENTAL

Cannabis - Medium Dose (10 mg)

Intervention Type: DRUG

Participants will consume a medium dose (10 mg) of cannabis edibles.

High Dose Cannabis Edibles (20 mg)

Participants consume a high dose of cannabis edibles (20 mg THC).

Group Type: EXPERIMENTAL

Cannabis - High Dose (20 mg)

Intervention Type: DRUG

Participants will consume a high dose (20 mg) of cannabis edibles.

Interventions

Cannabis - Placebo Dose (0 mg)

Participants will consume placebo cannabis edibles.

Intervention Type: DRUG

Cannabis - Low Dose (2 mg)

Participants will consume a low dose (2 mg) of cannabis edibles.

Intervention Type: DRUG

Cannabis - Medium Dose (10 mg)

Participants will consume a medium dose (10 mg) of cannabis edibles.

Intervention Type: DRUG

Cannabis - High Dose (20 mg)

Participants will consume a high dose (20 mg) of cannabis edibles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provides written and informed consent
• Stated the willingness to comply with all study procedures
• Recreational use of oral, vaped, smoked or edible cannabis (at least one day/week) and cannabis edibles (at least one day/month) confirmed by self-report and urine screening (i.e., positive THC result in point-of-care screening or Clinical Laboratory assay)
• Males and females aged 19 to 45 years
• Has held a class G license (or equivalent from another jurisdiction) for at least 12 months
• Willing to abstain from using cannabis for 72 hours prior to each practice or test session
• Willing to abstain from alcohol for 48 hours prior to each practice or test session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session)
• Lives within a radius that costs less than about $60 per taxi ride
• Able to consume the quantity of candies and drive the driving simulator as determined by a practice session
• A negative urine pregnancy test for those with childbearing potential
• Use of appropriate contraception for those with childbearing potential

Exclusion Criteria

• Diagnosis of severe medical or psychiatric condition (e.g., diagnosis of a severe mood or anxiety disorder, based on self-report
• Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder
• Regular user of medication that may affect cognitive functioning and/or driver performance (e.g. ADHD medication, benzodiazepines, stimulants, opioids)
• Regular user of illicit substances
• Personal or family history of schizophrenia or other psychotic disorder
• Pregnant, looking to become pregnant, or breastfeeding
• Concomitant therapy with sedative-hypnotics or other psychoactive drugs
• Severe laboratory abnormalities that could create safety issues based on the judgement of the Principal Investigator
• Cardiovascular or cerebrovascular disease
• Severe renal or liver disease
• Participation in another clinical or non-therapeutic study in the past month

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Le Foll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Center for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

074-2020

Identifier Type: -

Identifier Source: org_study_id