<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813602</url>
  </required_header>
  <id_info>
    <org_study_id>076/2018</org_study_id>
    <nct_id>NCT03813602</nct_id>
  </id_info>
  <brief_title>Detection of Cannabis Impairment With an Eye Tracker</brief_title>
  <acronym>ACS</acronym>
  <official_title>Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cannabis is one of the widely used psychoactive substances in the world. With increasing&#xD;
      legalization, the prevalence of driving under the influence of cannabis will undoubtedly&#xD;
      rise. At present, roadside detection of cannabis intoxication is largely dependent on drug&#xD;
      recognition experts who rely on changes in eye movements when impaired. In this regard, use&#xD;
      of eye trackers can help to detect impairment in drivers. The purpose of the present study is&#xD;
      to determine the feasibility of the use of eye trackers in detecting impairment in&#xD;
      participants who smoked a cannabis cigarette.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will attend one study session after determination of eligibility. During this&#xD;
      session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator.&#xD;
      Driving will be assessed prior to smoking cannabis and at 7 time points after smoking&#xD;
      cannabis. Eye tracking measures will also be taken while driving after smoking cannabis.&#xD;
      Blood will be drawn for determination of levels of the psychoactive substance THC and its&#xD;
      metabolites. Saliva tests, urine tests and subjective tests will also be performed at various&#xD;
      times points after smoking cannabis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2019</start_date>
  <completion_date type="Actual">November 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in eye gaze</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Measures of eye movement with an eye tracker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in saccades</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Measures of quick eye movements with an eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eye fixations</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Measure of where the eye is looking with an eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blinking rate</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The number of blinks, measured with an eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blinking duration</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The length of time that blinks last, measured with a eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blinking speed</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>How fast the blinking is, measured with an eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pupil size</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The diameter of pupils while driving, measured with an eye tracker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean speed on the driving simulator</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The speed, in km, while driving a driving simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standard deviation of speed on the driving simulator</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The amount of variation in speed while driving the driving simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximum speed on the driving simulator</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The greatest speed obtained on the driving simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standard deviation of lateral position on the driving simulator</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The amount of weaving while driving the driving simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in minimum time to collision on the driving simulator</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The time needed to collide with the car in front, while driving the simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of collisions</measure>
    <time_frame>baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The number of times a car impacts another car while driving the simulator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood concentrations of delta-9-tetrahydrocannabinol</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The levels of the psychoactive component of cannabis, THC, in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood concentrations of carboxy-tetrahydrocannabinol</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The levels of the inactive metabolite of THC in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The levels of the active metabolite of THC in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in saliva THC detection</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Detection of THC in saliva</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diastolic blood pressure</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in temperature</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of respirations per minute</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective cannabis effects with a visual analog scale</measure>
    <time_frame>baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours</time_frame>
    <description>The amount of liking of cannabis from 0 to 100, with 100 being the greatest value</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Cannabis Intoxication</condition>
  <arm_group>
    <arm_group_label>Cannabis sativa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a 750 mg cannabis cigarette with 12.5% THC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabis Sativa</intervention_name>
    <description>750 mg cannabis cigarette with 12.5% THC</description>
    <arm_group_label>Cannabis sativa</arm_group_label>
    <other_name>Marijuana</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care&#xD;
             testing;&#xD;
&#xD;
          -  19-26 years of age;&#xD;
&#xD;
          -  holds a class G or G2 Ontario driver's licence (or equivalent from another&#xD;
             jurisdiction) for at least 12 months;&#xD;
&#xD;
          -  Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to&#xD;
             the study session;&#xD;
&#xD;
          -  Willing to abstain from all other drugs not prescribed for medical purposes for the&#xD;
             duration of the study;&#xD;
&#xD;
          -  Provides written and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urine toxicology screens negative for cannabis upon eligibility assessment;&#xD;
&#xD;
          -  Diagnosis of severe medical or psychiatric conditions;&#xD;
&#xD;
          -  Females: Pregnancy or breastfeeding;&#xD;
&#xD;
          -  Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);&#xD;
&#xD;
          -  Is a regular user of medications that affect brain function (i.e., antidepressants,&#xD;
             benzodiazepines, stimulants);&#xD;
&#xD;
          -  First-degree relative diagnosed with schizophrenia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard Le Foll, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addition and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813602
org study id: 076/2018
nct id: NCT03813602
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Change in eye gaze
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Measures of eye movement with an eye tracker
measure: Change in saccades
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Measures of quick eye movements with an eye tracker
measure: Change in eye fixations
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Measure of where the eye is looking with an eye tracker
measure: Change in blinking rate
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: The number of blinks, measured with an eye tracker
measure: Change in blinking duration
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: The length of time that blinks last, measured with a eye tracker
measure: Change in blinking speed
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: How fast the blinking is, measured with an eye tracker
measure: Change in pupil size
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: The diameter of pupils while driving, measured with an eye tracker
measure: 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
description: The speed, in km, while driving a driving simulator
measure: 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
description: The amount of variation in speed while driving the driving simulator
measure: 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
description: The greatest speed obtained on the driving simulator
measure: 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
description: The amount of weaving while driving the driving simulator
measure: 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
description: The time needed to collide with the car in front, while driving the simulator
measure: Change in number of collisions
time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: The number of times a car impacts another car while driving the simulator
measure: 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
description: The levels of the psychoactive component of cannabis, THC, in blood
measure: Change in blood concentrations of carboxy-tetrahydrocannabinol
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: The levels of the inactive metabolite of THC in blood
measure: 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
description: The levels of the active metabolite of THC in blood
measure: Change in saliva THC detection
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Detection of THC in saliva
measure: Change in systolic blood pressure
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Vital signs
measure: Change in diastolic blood pressure
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Vital signs
measure: Change in heart rate
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Vital signs
measure: Change in temperature
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Vital signs
measure: Change in number of respirations per minute
time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
description: Vital signs
measure: 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
description: The amount of liking of cannabis from 0 to 100, with 100 being the greatest value
arm group label: Cannabis sativa
arm group type: Experimental
description: a 750 mg cannabis cigarette with 12.5% THC
intervention type: Drug
intervention name: Cannabis Sativa
description: 750 mg cannabis cigarette with 12.5% THC
arm group label: Cannabis sativa
other name: Marijuana
criteria: 
gender: All
minimum age: 19 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bernard Le Foll, MD PhD
role: Principal Investigator
affiliation: Centre for Addition and Mental Health
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Marijuana Abuse
sharing ipd: Undecided