Neural Correlates of Driving and Cannabis

Sponsor
Unity Health Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT03581058
Collaborator
University Health Network, Toronto (Other)
12
1
3
28.8
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigating the Neural Correlates of Driving After Medical Cannabis Exposure
Actual Study Start Date :
Aug 8, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cannabis - Jean Guy

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

Drug: Cannabis
Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
Other Names:
  • Marijuana
  • Experimental: Cannabis - Churchill

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

    Drug: Cannabis
    Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
    Other Names:
  • Marijuana
  • No Intervention: Sober

    All participants will complete same tasks sober.

    Outcome Measures

    Primary Outcome Measures

    1. Change in neural activation on fMRI during driving simulation [30-60 min after cannabis intake vs sober]

      Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.

    Secondary Outcome Measures

    1. Performance on driving simulator [30-60 min after cannabis intake vs sober]

      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.

    2. Performance on cognitive tasks [60-90 min after cannabis intake vs sober]

      Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.

    3. Blood plasma concentration levels of cannabinoids [10 min and 60 min after cannabis intake]

      Concentration levels of THC and CBD throughout the session duration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • Unity Health Toronto
    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Tom Schweizer, PhD, Unity Health Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Unity Health Toronto
    ClinicalTrials.gov Identifier:
    NCT03581058
    Other Study ID Numbers:
    • 17-206
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Unity Health Toronto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2020