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Detection of Cannabis Impairment With an Eye Tracker (ACS)

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ClinicalTrials.gov Identifier: NCT03813602
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Cannabis Intoxication Drug: Cannabis Sativa Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
Estimated Study Start Date : July 4, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Cannabis sativa
a 750 mg cannabis cigarette with 12.5% THC
Drug: Cannabis Sativa
750 mg cannabis cigarette with 12.5% THC
Other Name: Marijuana




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Change in systolic blood pressure [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs

  18. Change in diastolic blood pressure [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs

  19. Change in heart rate [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs

  20. Change in temperature [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs

  21. 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

  22. 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



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Ages Eligible for Study:   19 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03813602


Contacts
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Contact: Christine Wickens, PhD 416 535-8501 ext 34711 christine.iwickens@camh.ca
Contact: Patricia Di Ciano, PhD 416 535-8501 ext 34002 patricia.diciano@camh.ca

Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Bernard Le Foll, MD PhD Centre for Addition and Mental Health

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Responsible Party: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03813602     History of Changes
Other Study ID Numbers: 076/2018
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders