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NCT Number: NCT04325958

Age Differences in the Effects of Cannabis on Simulated Driving

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

Recruiting

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location status: Recruiting

Location contact

Christine Wickens, PhD

CONTACT

[email protected]

416-535-8501 ext. 34711

About this study

Epidemiological studies have established that the use of cannabis can increase the risk of a motor vehicle collision. A number of variables can influence the effects of cannabis on driving. For example, frequent users of cannabis have been shown to have different cognitive and physiological responses to cannabis as compared to occasional users. In addition, we know that younger drivers are more likely to be involved in motor vehicle collisions after alcohol use as compared to older users. The contribution of age and experience with cannabis on cannabis-mediated effects on driving have yet to be delineated in laboratory studies. The purpose of the present investigation will be to determine whether cannabis has different effects on driving in young, as compared to middle aged, drivers. Half of each age group will be occasional users of cannabis and the other half will be frequent users.

Eligible participants will attend the laboratory for two test sessions; in one session they will smoke a cannabis cigarette and in the other they smoke a placebo cigarette. Participants will drive a driving simulator before and after smoking the cigarette. Blood for measurement of THC and metabolites will also be collected before smoking the cigarette and at a number of times after smoking. Subjective and cognitive tasks will be completed before and after smoking.

It is hoped that the findings of this study will help to inform public perception and policy into the potential effects of cannabis on driving.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19-25 or 35-45 years of age;
  • Use of smoked cannabis at least once in the past 6 months.
  • Use of smoked or vaped cannabis primarily for recreational purposes on up to 1 day per week or on at least 6 days per week in the past 3 months;
  • Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
  • Willing to abstain from using alcohol for 24 hours and cannabis for 72 hours prior to Practice and Test Sessions;
  • Willing to abstain from all other drugs not prescribed for medical purposes for 48 hours prior to Practice and Test Sessions;
  • Resides within Toronto (study site) or can reside with friends/family in Toronto after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;
  • Participant willing to use appropriate contraception until their participation in the study is completed;
  • Provides written and informed consent.

Exclusion criteria

  • Use of cannabis primarily for therapeutic purposes, or equally for therapeutic and recreational purposes;
  • Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Principal Investigator and a study physician; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease, and bleeding disorders. Smoking cannabis is not recommended for individuals with respiratory diseases, and they will be excluded;
  • Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report or SCID-5;
  • Participants of childbearing potential: Pregnancy (point-of-care test) or breastfeeding;
  • Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder;
  • Is a regular user of medications that affect brain function (based on self-report); this includes concomitant therapy with sedative-hypnotics or other psychoactive drugs
  • Use of anti-hypertensives;
  • First-degree relative diagnosed with schizophrenia or another psychotic disorder.
  • Participation in a past driving study at CAMH (to limit practice effects).
  • Participation in a clinical study concurrent with their participation in this study.

Treatment and study plan

Cannabis

Drug

750mg cigarette of plant material

Other names: Marijuana

Placebos

Drug

750mg cigarette of plant material

Other names: Dummy

Primary outcomes

  1. Standard deviation of lateral position

    Time frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure

    A measure of 'weaving' when driving the simulator (meters)

Secondary outcomes

  1. Mean speed

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    A measure of the average speed while driving the simulator (km/hr)

  2. Standard deviation of speed

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    A measure of the variability in speed while driving the simulator (km/hr)

  3. Maximum speed

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    A measure of the greatest speed obtained while driving the simulator (in km/hr)

  4. Following distance

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    A measure of the distance between the car being driven and the car in front (meters)

  5. Braking latency

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    A measure of the time it takes to move the foot from the gas pedal to the brake when a stop sign is encountered (seconds)

  6. Number of collisions

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

    The number of collisions while driving the simulator (total number)

  7. Blood concentration of delta-9-tetrahydrocannabinol (THC)

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis

    A measure of the psychoactive component of cannabis in blood (ng/ml)

  8. Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH)

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis

    A measure of the inactive metabolite of cannabis in blood (ng/ml)

  9. Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC)

    Time frame: Before cannabis exposure and 25 minutes and 2 hours after cannabis

    A measure of the active metabolite of cannabis in blood (ng/ml)

  10. Systolic blood pressure

    Time frame: Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis

    A vital sign (mmHg)

  11. Diastolic blood pressure

    Time frame: Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis

    A vital sign (mmHg)

  12. Heart rate

    Time frame: Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis

    A vital sign (beats/minute)

  13. Visual Analog Scales such as 'I feel this effect', 'I like this drug effect', 'I feel the good effects'

    Time frame: Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis

    A measure of the subjective effects of cannabis (on a scale of 0 to 100, where is 100 is the strongest level of agreement)

  14. Trail Making Test

    Time frame: Before cannabis exposure and 70 minutes after cannabis

    A measure of the cognitive effects of cannabis (performance speed in seconds)

  15. Verbal Free Recall Task

    Time frame: Before cannabis exposure and 70 minutes after cannabis

    A measure of the cognitive effects of cannabis (number correct)

  16. Grooved Pegboard Test

    Time frame: Before cannabis exposure and 70 minutes after cannabis

    A measure of the cognitive effects of cannabis (performance speed in milliseconds)

  17. Simple and Choice Reaction Time Tasks

    Time frame: Before cannabis exposure and 70 minutes after cannabis

    A measure of the cognitive effects of cannabis (milliseconds)

  18. Vienna Risk-Taking Test

    Time frame: One hour after cannabis exposure

    A measure of the amount of risk-taking (latency)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Wickens, PhD

CONTACT

[email protected]

416 535-8501 ext. 34711

Gina Stoduto

CONTACT

[email protected]

416 535-8501 ext. 34499

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors

Acronym: ADCUF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2020
Registry last updated
Mar 23, 2026

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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