Detection of Cannabis Impairment With an Eye Tracker (ACS)

December 11, 2019 updated by: Centre for Addiction and Mental Health

Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Center for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cannabis sativa
a 750 mg cannabis cigarette with 12.5% THC
Drug: Cannabis Sativa
750 mg cannabis cigarette with 12.5% THC
Other Names:
  • Marijuana

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in eye gaze
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Measures of eye movement with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in saccades
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Measures of quick eye movements with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in eye fixations
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Measure of where the eye is looking with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking rate
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The number of blinks, measured with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking duration
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The length of time that blinks last, measured with a eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking speed
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
How fast the blinking is, measured with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in pupil size
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The diameter of pupils while driving, measured with an eye tracker
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in mean speed on the driving simulator
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The speed, in km, while driving a driving simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of speed on the driving simulator
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The amount of variation in speed while driving the driving simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in maximum speed on the driving simulator
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The greatest speed obtained on the driving simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of lateral position on the driving simulator
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The amount of weaving while driving the driving simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in minimum time to collision on the driving simulator
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The time needed to collide with the car in front, while driving the simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of collisions
Time Frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The number of times a car impacts another car while driving the simulator
baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of delta-9-tetrahydrocannabinol
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The levels of the psychoactive component of cannabis, THC, in blood
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of carboxy-tetrahydrocannabinol
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The levels of the inactive metabolite of THC in blood
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The levels of the active metabolite of THC in blood
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in saliva THC detection
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Detection of THC in saliva
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in systolic blood pressure
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Vital signs
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in diastolic blood pressure
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Vital signs
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in heart rate
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Vital signs
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in temperature
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Vital signs
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of respirations per minute
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Vital signs
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in Subjective cannabis effects with a visual analog scale
Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
The amount of liking of cannabis from 0 to 100, with 100 being the greatest value
baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernard Le Foll, MD PhD, Centre for Addition and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 076/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings