Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neural Correlates of Driving and Cannabis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581058
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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
Cannabis Use Driving Impaired Drug: Cannabis Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: 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 Name: Marijuana

No Intervention: Sober
All participants will complete same tasks sober.



Primary Outcome Measures :
  1. Change in neural activation on fMRI during driving simulation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 min and 60 min after cannabis intake ]
    Concentration levels of THC and CBD throughout the session duration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581058


Contacts
Layout table for location contacts
Contact: Tom Schweizer, PhD 416-864-6060 ext 77342 schweizert@smh.ca

Locations
Layout table for location information
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Hance Clarke, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Tom Schweizer, PhD St. Michael's Hospital, Toronto

Layout table for additonal information
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03581058     History of Changes
Other Study ID Numbers: 17-206
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Michael's Hospital, Toronto:
MRI
Cannabis
Driving
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders