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CannabisNCT06595576

Cannabis Edibles and Simulated Driving

A study testing Cannabis - Low Dose (2 mg), Cannabis - Medium Dose (10 mg) and Cannabis - High Dose (20 mg) in people with Cannabis and Driving Under the Influence, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, Driving Under the Influence
What is being tested?
Cannabis - Low Dose (2 mg), Cannabis - Medium Dose (10 mg) and Cannabis - High Dose (20 mg)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteCanada
Study dates
1 Oct 2024to 4 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Center for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance

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.
Being tested
Cannabis - Placebo Dose (0 mg), Cannabis - Low Dose (2 mg), Cannabis - Medium Dose (10 mg), Cannabis - High Dose (20 mg)
Keywords
Cannabis Edibles, THC, Driving Simulator, Cognition, Subjective Effects, Cannabinoids
Medical subject headings
Marijuana Abuse, Driving Under the Influence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06595576
Study groupRoleWhat they receive
Placebo Cannabis Edibles (0 mg THC)ExperimentalParticipants consume a placebo dose of cannabis edibles (0 mg THC).
Receives: Drug: Cannabis - Placebo Dose (0 mg)
Low Dose Cannabis Edibles (2 mg THC)ExperimentalParticipants consume a low dose of cannabis edibles (2 mg THC).
Receives: Drug: Cannabis - Low Dose (2 mg)
Medium Dose Cannabis Edibles (10 mg)ExperimentalParticipants consume a medium dose of cannabis edibles (10 mg THC).
Receives: Drug: Cannabis - Medium Dose (10 mg)
High Dose Cannabis Edibles (20 mg)ExperimentalParticipants consume a high dose of cannabis edibles (20 mg THC).
Receives: Drug: Cannabis - High Dose (20 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Standard Deviation of Lateral Position (SDLP)

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

    Measured: 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)
  1. Mean Speed (MS)

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

    Measured: 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.

  2. Reaction Time (RT)

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

    Measured: 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.

  3. Standard Deviation of Speed (SDS)

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

    Measured: 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.

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

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

    Measured: 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.

  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

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

    Measured: 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.

  6. Heart Rate

    Heart rate (bpm) will be measured.

    Measured: 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.

  7. Blood Pressure

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

    Measured: 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.

  8. Temperature

    Temperature (degrees Celsius) will be measured.

    Measured: 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.

  9. Visual Analog Scale (VAS)

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

    Measured: 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.

  10. Addiction Research Centre Inventory (ARCI)

    Used to assess subjective effects of cannabis.

    Measured: 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.

  11. Profile of Mood States (POMS)

    Used to assess subjective effects of cannabis.

    Measured: 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.

  12. Verbal Free Recall Task

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

    Measured: 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.

  13. Blood Concentrations of mtDNA

    Used to assess concentrations of mtDNA.

    Measured: 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.

  14. Blood Concentrations Endocannabinoids

    Used to assess concentrations of endocannabinoids.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595576
Sponsor's protocol ID
074-2020
Status last verified
Feb 2025
First submitted
6 Sep 2024
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Le Foll B, Matheson J, Antwi P, Wright M, Zaweel A, Hasan OSM, Kloiber S, Hassan AN, Sproule B, Wickens CM, Di Ciano P, Brands B. Dose-Dependent Effects of Cannabis Edibles on Simulated Driving Performance: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2631306. doi: 10.1001/jamanetworkopen.2026.31306.

    PubMed 42671837

Questions about this trial

What is this clinical trial studying?

A study testing Cannabis - Low Dose (2 mg), Cannabis - Medium Dose (10 mg) and Cannabis - High Dose (20 mg) in people with Cannabis and Driving Under the Influence, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06595576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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