Status:
COMPLETED
Cannabis Edibles and Simulated Driving
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Cannabis
Driving Under the Influence
Eligibility:
All Genders
19-45 years
Phase:
NA
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06595576
Start Date
October 1 2024
End Date
April 4 2025
Last Update
August 3 2025
Active Locations (1)
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1
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1