NCT04325958 Age Differences in the Effects of Cannabis on Simulated Driving
| NCT ID | NCT04325958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Cannabis |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2024-03-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Christine Wickens, PhD
PRINCIPAL INVESTIGATOR
Centre for Addiction and Mental Health
Frequently Asked Questions
Who can join the NCT04325958 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 45 Years, studying Cannabis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04325958 currently recruiting?
Yes, NCT04325958 is actively recruiting participants. Contact the research team at christine.wickens@camh.ca for enrollment information.
Where is the NCT04325958 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04325958 clinical trial?
NCT04325958 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Christine Wickens, PhD at Centre for Addiction and Mental Health. The trial plans to enroll 128 participants.