NCT03581058

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. 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. 2.compare participant's performance on cognitive tasks while under the influence of cannabis and sober;
  3. 3.look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;
  4. 4.correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

June 6, 2018

Last Update Submit

March 20, 2020

Conditions

Cannabis UseDriving Impaired

Keywords

MRICannabisDriving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Performance on driving simulator

    30-60 min after cannabis intake vs sober

  • Performance on cognitive tasks

    60-90 min after cannabis intake vs sober

  • Blood plasma concentration levels of cannabinoids

    10 min and 60 min after cannabis intake

Study Arms (3)

Cannabis - Jean Guy

EXPERIMENTAL

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

Drug: Cannabis

Cannabis - Churchill

EXPERIMENTAL

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

Drug: Cannabis

Sober

NO INTERVENTION

All participants will complete same tasks sober.

Interventions

CannabisDRUG

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

Also known as: Marijuana
Cannabis - ChurchillCannabis - Jean Guy

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Tom Schweizer, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 10, 2018

Study Start

August 8, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)