Recruiting

Cannabis

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT04325958

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

Interventions

Cannabis

Placebos

Study Details

Brief summary:

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.

Conditions

Cannabis

Study ID

NCT04325958

Start date

Mar 27, 2024

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Age group 19 to 25

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

other: Age group 35 to 45

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

Interventions

Cannabis

750mg cigarette of plant material

Placebos

750mg cigarette of plant material

Primary outcome measure

  • Standard deviation of lateral position [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]

Central Contacts and Locations

Central contacts

Christine Wickens, PhD

416 535-8501christine.wickens@camh.ca

Gina Stoduto

416 535-8501gina.stoduto@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5S 2S1

Contacts

Christine Wickens, PhD

416-535-8501christine.wickens@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-23.