Cannabis Edibles and Simulated Driving

NCT06595576 | Completed

• 1 other identifier: 074-2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Cannabis Edibles; THC; Driving Simulator; Cognition; Subjective Effects; Cannabinoids

Outcome Measures

Primary Outcomes (1)

• Standard Deviation of Lateral Position (SDLP)

  The driving simulator will objectively record SDLP during a number of pre-programmed driving scenarios.

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

Secondary Outcomes (14)

• Mean Speed (MS)

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

• Reaction Time (RT)

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

• Standard Deviation of Speed (SDS)

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

• Blood concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

• Oral fluid concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) and point-of-care detection of cannabinoids

  Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.

Study Arms (4)

Placebo Cannabis Edibles (0 mg THC)

EXPERIMENTAL

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

Drug: Cannabis - Placebo Dose (0 mg)

Low Dose Cannabis Edibles (2 mg THC)

EXPERIMENTAL

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

Drug: Cannabis - Low Dose (2 mg)

Medium Dose Cannabis Edibles (10 mg)

EXPERIMENTAL

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

Drug: Cannabis - Medium Dose (10 mg)

High Dose Cannabis Edibles (20 mg)

EXPERIMENTAL

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

Drug: Cannabis - High Dose (20 mg)

Interventions

Cannabis - Placebo Dose (0 mg) DRUG

Participants will consume placebo cannabis edibles.

Placebo Cannabis Edibles (0 mg THC)

Cannabis - Low Dose (2 mg) DRUG

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

Low Dose Cannabis Edibles (2 mg THC)

Cannabis - Medium Dose (10 mg) DRUG

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

Medium Dose Cannabis Edibles (10 mg)

Cannabis - High Dose (20 mg) DRUG

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

High Dose Cannabis Edibles (20 mg)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse; Driving Under the Influence

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Criminal Behavior; Behavior; Dangerous Behavior

Study Officials

• Bernard Le Foll, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a within-subjects, double-blind, placebo-controlled, randomized and counterbalanced human laboratory experiment assessing the effects of a range of doses of cannabis edibles on driving simulator performance. These 4 drug exposure conditions are: placebo, low dose (2 + 2% mg THC), medium dose (10 + 2% mg THC), and high dose (20 + 2% mg THC).

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-02

Locations

CA (1)