Neural Correlates of Driving and Cannabis
Primary Purpose
Cannabis Use, Driving Impaired
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cannabis
Sponsored by
About this trial
This is an interventional other trial for Cannabis Use focused on measuring MRI, Cannabis, Driving
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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cannabis - Jean Guy
Cannabis - Churchill
Sober
Arm Description
A participant will be administered 1g of Jean Guy strain of cannabis.
A participant will be administered 1g of Churchill strain of cannabis.
All participants will complete same tasks sober.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Performance on cognitive tasks
Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.
Blood plasma concentration levels of cannabinoids
Concentration levels of THC and CBD throughout the session duration
Full Information
NCT ID
NCT03581058
First Posted
June 6, 2018
Last Updated
March 20, 2020
Sponsor
Unity Health Toronto
Collaborators
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03581058
Brief Title
Neural Correlates of Driving and Cannabis
Official Title
Investigating the Neural Correlates of Driving After Medical Cannabis Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;
compare participant's performance on cognitive tasks while under the influence of cannabis and sober;
look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;
correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Driving Impaired
Keywords
MRI, Cannabis, Driving
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabis - Jean Guy
Arm Type
Experimental
Arm Description
A participant will be administered 1g of Jean Guy strain of cannabis.
Arm Title
Cannabis - Churchill
Arm Type
Experimental
Arm Description
A participant will be administered 1g of Churchill strain of cannabis.
Arm Title
Sober
Arm Type
No Intervention
Arm Description
All participants will complete same tasks sober.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
Primary Outcome Measure Information:
Title
Change in neural activation on fMRI during driving simulation
Description
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
Secondary Outcome Measure Information:
Title
Performance on driving simulator
Description
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
Title
Performance on cognitive tasks
Description
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
Title
Blood plasma concentration levels of cannabinoids
Description
Concentration levels of THC and CBD throughout the session duration
Time Frame
10 min and 60 min after cannabis intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Schweizer, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neural Correlates of Driving and Cannabis
We'll reach out to this number within 24 hrs