Age Differences in the Effects of Cannabis on Simulated Driving

NCT04325958 | Recruiting

• 1 other identifier: 048/2019
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Standard deviation of lateral position

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

  Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure

Secondary Outcomes (18)

• Mean speed

  Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

• Standard deviation of speed

  Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

• Maximum speed

  Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

• Following distance

  Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

• Braking latency

  Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure

Study Arms (2)

Age group 19 to 25

OTHER

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).

Drug: Cannabis; Drug: Placebos

Age group 35 to 45

OTHER

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).

Drug: Cannabis; Drug: Placebos

Interventions

Cannabis DRUG

750mg cigarette of plant material

Also known as: Marijuana

Age group 19 to 25; Age group 35 to 45

Placebos DRUG

750mg cigarette of plant material

Also known as: Dummy

Age group 19 to 25; Age group 35 to 45

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christine Wickens, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Wickens, PhD

CONTACT

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

Gina Stoduto

CONTACT

416 535-8501; gina.stoduto@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete a session with active cannabis and a session with placebo cannabis. Order of sessions is randomized. Participants and Investigator are blinded. Allocation to arms is not randomized. Arms are based on their age.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: March 27, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)