Neural Correlates of Driving and Cannabis

NCT ID: NCT03581058

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2020-12-31

Brief 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.

Conditions

Cannabis Use; Driving Impaired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cannabis - Jean Guy

A participant will be administered 1g of Jean Guy strain of cannabis.

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

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

Cannabis - Churchill

A participant will be administered 1g of Churchill strain of cannabis.

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

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

Sober

All participants will complete same tasks sober.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cannabis

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

Intervention Type: DRUG

Other Intervention Names

Marijuana

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Schweizer, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

17-206

Identifier Type: -

Identifier Source: org_study_id