Neural Correlates of Driving and Cannabis

Cannabis Use Clinical Trial

Official title:

Investigating the Neural Correlates of Driving After Medical Cannabis Exposure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03581058
• Other study ID #: 17-206
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 8, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;

2. compare participant's performance on cognitive tasks while under the influence of cannabis and sober;

3. look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;

4. correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 59 Years

Eligibility

Inclusion Criteria:

• valid driver's license

• have normal or corrected-to-normal vision

• have had prior experience consuming cannabis

• are currently not and have not been regular users in the past 5 years (regular use is defined as at least 1 time per week for at least 1 month)

• prescribed medical cannabis

Exclusion Criteria:

• not fluent in English

• do not meet MRI screening criteria

• use 50 mg/day of morphine equivalents

• history of neurological, neurodegenerative or psychiatric diseases

• any serious sensory or motor impairments

• pregnant women or women trying to get pregnant, or breastfeeding

• serious lung, liver, kidney, and heart problems, including angina, coronary artery disease, and arrhythmia, and Peripheral Vascular Disease

• personal or family history of mental disorders or alcohol or drug abuse or dependence

Related Conditions & MeSH terms

• Cannabis Use
• Driving Impaired
• Marijuana Abuse

Intervention

Drug:
• Cannabis
Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30-60 min after cannabis intake vs sober
Secondary	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.	30-60 min after cannabis intake vs sober
Secondary	Performance on cognitive tasks	Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.	60-90 min after cannabis intake vs sober
Secondary	Blood plasma concentration levels of cannabinoids	Concentration levels of THC and CBD throughout the session duration	10 min and 60 min after cannabis intake