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Detection of Cannabis Impairment With an Eye Tracker (ACS)

Primary Purpose

Cannabis Intoxication

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cannabis Sativa
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cannabis Intoxication

Eligibility Criteria

19 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
  • 19-26 years of age;
  • holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
  • Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session;
  • Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
  • Provides written and informed consent.

Exclusion Criteria:

  • Urine toxicology screens negative for cannabis upon eligibility assessment;
  • Diagnosis of severe medical or psychiatric conditions;
  • Females: Pregnancy or breastfeeding;
  • Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
  • Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
  • First-degree relative diagnosed with schizophrenia.

Sites / Locations

  • Center for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabis sativa

Arm Description

a 750 mg cannabis cigarette with 12.5% THC

Outcomes

Primary Outcome Measures

Change in eye gaze
Measures of eye movement with an eye tracker

Secondary Outcome Measures

Change in saccades
Measures of quick eye movements with an eye tracker
Change in eye fixations
Measure of where the eye is looking with an eye tracker
Change in blinking rate
The number of blinks, measured with an eye tracker
Change in blinking duration
The length of time that blinks last, measured with a eye tracker
Change in blinking speed
How fast the blinking is, measured with an eye tracker
Change in pupil size
The diameter of pupils while driving, measured with an eye tracker
Change in mean speed on the driving simulator
The speed, in km, while driving a driving simulator
Change in standard deviation of speed on the driving simulator
The amount of variation in speed while driving the driving simulator
Change in maximum speed on the driving simulator
The greatest speed obtained on the driving simulator
Change in standard deviation of lateral position on the driving simulator
The amount of weaving while driving the driving simulator
Change in minimum time to collision on the driving simulator
The time needed to collide with the car in front, while driving the simulator
Change in number of collisions
The number of times a car impacts another car while driving the simulator
Change in blood concentrations of delta-9-tetrahydrocannabinol
The levels of the psychoactive component of cannabis, THC, in blood
Change in blood concentrations of carboxy-tetrahydrocannabinol
The levels of the inactive metabolite of THC in blood
Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
The levels of the active metabolite of THC in blood
Change in saliva THC detection
Detection of THC in saliva
Change in systolic blood pressure
Vital signs
Change in diastolic blood pressure
Vital signs
Change in heart rate
Vital signs
Change in temperature
Vital signs
Change in number of respirations per minute
Vital signs
Change in Subjective cannabis effects with a visual analog scale
The amount of liking of cannabis from 0 to 100, with 100 being the greatest value

Full Information

First Posted
January 16, 2019
Last Updated
December 11, 2019
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03813602
Brief Title
Detection of Cannabis Impairment With an Eye Tracker
Acronym
ACS
Official Title
Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.
Detailed Description
Participants will attend one study session after determination of eligibility. During this session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator. Driving will be assessed prior to smoking cannabis and at 7 time points after smoking cannabis. Eye tracking measures will also be taken while driving after smoking cannabis. Blood will be drawn for determination of levels of the psychoactive substance THC and its metabolites. Saliva tests, urine tests and subjective tests will also be performed at various times points after smoking cannabis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Intoxication

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis sativa
Arm Type
Experimental
Arm Description
a 750 mg cannabis cigarette with 12.5% THC
Intervention Type
Drug
Intervention Name(s)
Cannabis Sativa
Other Intervention Name(s)
Marijuana
Intervention Description
750 mg cannabis cigarette with 12.5% THC
Primary Outcome Measure Information:
Title
Change in eye gaze
Description
Measures of eye movement with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary Outcome Measure Information:
Title
Change in saccades
Description
Measures of quick eye movements with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in eye fixations
Description
Measure of where the eye is looking with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blinking rate
Description
The number of blinks, measured with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blinking duration
Description
The length of time that blinks last, measured with a eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blinking speed
Description
How fast the blinking is, measured with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in pupil size
Description
The diameter of pupils while driving, measured with an eye tracker
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in mean speed on the driving simulator
Description
The speed, in km, while driving a driving simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in standard deviation of speed on the driving simulator
Description
The amount of variation in speed while driving the driving simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in maximum speed on the driving simulator
Description
The greatest speed obtained on the driving simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in standard deviation of lateral position on the driving simulator
Description
The amount of weaving while driving the driving simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in minimum time to collision on the driving simulator
Description
The time needed to collide with the car in front, while driving the simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in number of collisions
Description
The number of times a car impacts another car while driving the simulator
Time Frame
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blood concentrations of delta-9-tetrahydrocannabinol
Description
The levels of the psychoactive component of cannabis, THC, in blood
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blood concentrations of carboxy-tetrahydrocannabinol
Description
The levels of the inactive metabolite of THC in blood
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
Description
The levels of the active metabolite of THC in blood
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in saliva THC detection
Description
Detection of THC in saliva
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in systolic blood pressure
Description
Vital signs
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in diastolic blood pressure
Description
Vital signs
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in heart rate
Description
Vital signs
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in temperature
Description
Vital signs
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in number of respirations per minute
Description
Vital signs
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Title
Change in Subjective cannabis effects with a visual analog scale
Description
The amount of liking of cannabis from 0 to 100, with 100 being the greatest value
Time Frame
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing; 19-26 years of age; holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months; Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session; Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study; Provides written and informed consent. Exclusion Criteria: Urine toxicology screens negative for cannabis upon eligibility assessment; Diagnosis of severe medical or psychiatric conditions; Females: Pregnancy or breastfeeding; Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV); Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants); First-degree relative diagnosed with schizophrenia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD PhD
Organizational Affiliation
Centre for Addition and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34432541
Citation
Shahidi Zandi A, Comeau FJE, Mann RE, Di Ciano P, Arslan EP, Murphy T, Le Foll B, Wickens CM. Preliminary Eye-Tracking Data as a Nonintrusive Marker for Blood Delta-9-Tetrahydrocannabinol Concentration and Drugged Driving. Cannabis Cannabinoid Res. 2021 Dec;6(6):537-547. doi: 10.1089/can.2020.0141. Epub 2021 Aug 24.
Results Reference
derived

Learn more about this trial

Detection of Cannabis Impairment With an Eye Tracker

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