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Completed

NCT Number: NCT06595576

Cannabis Edibles and Simulated Driving

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.

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Key information

Conditions

Cannabis Behavior Chemically-Induced Disorders Criminal Behavior Dangerous Behavior Driving Under the Influence Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis - Placebo Dose (0 mg)

Drug

Participants will consume placebo cannabis edibles.

Cannabis - Low Dose (2 mg)

Drug

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

Cannabis - Medium Dose (10 mg)

Drug

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

Cannabis - High Dose (20 mg)

Drug

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

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP)

    Time frame: 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.

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

Secondary outcomes

  1. Mean Speed (MS)

    Time frame: 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.

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

  2. Reaction Time (RT)

    Time frame: 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.

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

  3. Standard Deviation of Speed (SDS)

    Time frame: 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.

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

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

    Time frame: 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.

    Used to assess THC and metabolite concentrations (ng/mL) in blood.

  5. 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

    Time frame: 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.

    Used to assess THC and metabolite concentrations (ng/mL) in oral fluid.

  6. Heart Rate

    Time frame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.

    Heart rate (bpm) will be measured.

  7. Blood Pressure

    Time frame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.

    Systolic and diastolic blood pressure (mmHg) will be measured.

  8. Temperature

    Time frame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.

    Temperature (degrees Celsius) will be measured.

  9. Visual Analog Scale (VAS)

    Time frame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.

    Used to assess subjective effects of cannabis on a sliding scale of 0 (not at all) to 100 (maximum effect).

  10. Addiction Research Centre Inventory (ARCI)

    Time frame: 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.

    Used to assess subjective effects of cannabis.

  11. Profile of Mood States (POMS)

    Time frame: 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.

    Used to assess subjective effects of cannabis.

  12. Verbal Free Recall Task

    Time frame: 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.

    Used to assess the impact of cannabis on verbal learning and memory.

  13. Blood Concentrations of mtDNA

    Time frame: 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.

    Used to assess concentrations of mtDNA.

  14. Blood Concentrations Endocannabinoids

    Time frame: 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.

    Used to assess concentrations of endocannabinoids.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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