A Phase 1 interventional study of Cannabis in Cannabis Use and Driving Impaired, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to participants aged 25 Years to 59 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Unity Health Toronto · Phase 1, Interventional, and Other
Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision.
The current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers.
The goals of the study are:
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A participant will be administered 1g of Jean Guy strain of cannabis.
Drug: Cannabis
A participant will be administered 1g of Churchill strain of cannabis.
Drug: Cannabis
All participants will complete same tasks sober.
Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
Also known as: Marijuana
Change in neural activation on fMRI during driving simulation
Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.
Time frame: 30-60 min after cannabis intake vs sober
Performance on driving simulator
Number of errors while completing driving tasks (e.g. turning, driving straight, speed maintenance, missed stop signs, etc.) under the influence of cannabis and sober.
Time frame: 30-60 min after cannabis intake vs sober
Performance on cognitive tasks
Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.
Time frame: 60-90 min after cannabis intake vs sober
Blood plasma concentration levels of cannabinoids
Concentration levels of THC and CBD throughout the session duration
Time frame: 10 min and 60 min after cannabis intake
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto