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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

Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date May 3, 2019
Estimated Study Start Date  ICMJE July 4, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03813602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change in systolic blood pressure [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs
  • Change in diastolic blood pressure [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs
  • Change in heart rate [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs
  • Change in temperature [ Time Frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours ]
    Vital signs
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Cannabis Impairment With an Eye Tracker
Official Title  ICMJE Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Cannabis Intoxication
Intervention  ICMJE Drug: Cannabis Sativa
750 mg cannabis cigarette with 12.5% THC
Other Name: Marijuana
Study Arms  ICMJE Experimental: Cannabis sativa
a 750 mg cannabis cigarette with 12.5% THC
Intervention: Drug: Cannabis Sativa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 26 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03813602
Other Study ID Numbers  ICMJE 076/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernard Le Foll, MD PhD Centre for Addition and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP