<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/NCT03804840</url>
  </required_header>
  <id_info>
    <org_study_id>AIS</org_study_id>
    <nct_id>NCT03804840</nct_id>
  </id_info>
  <brief_title>Developing a Mobile Method to Measure THC-induced Impairment</brief_title>
  <acronym>AIS</acronym>
  <official_title>A Mobile Prototype for a Field Sobriety Test for Cannabis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly&#xD;
      common as states remove restrictions on use. The increased use raises new concern about the&#xD;
      safety of this drug, including its ability to impair basic cognitive and psychomotor tasks,&#xD;
      and whether the users are aware of their impairment. We propose to design a simple&#xD;
      performance test that users can use in the field, using a cell phone, to assess their level&#xD;
      of impairment relative to their own drug-free state. In this preliminary study, we will&#xD;
      compare participants' simple task performance after a known dose of&#xD;
      delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions.&#xD;
      In our app the participants will be asked to gauge their own perceived level of impairment&#xD;
      (as determined by self-ratings and judgments of impairment) as well as their actual&#xD;
      impairment (as gauged by the app), providing important feedback and training about their&#xD;
      ability to detect impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Simple Reaction Time</measure>
    <time_frame>Assessed two hour post intervention at peak effects</time_frame>
    <description>In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Measuring THC-induced Cognitive Impairment Using a Mobile Application</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>7.5 mg THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>15 mg THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dronabinol</intervention_name>
    <description>THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).</description>
    <arm_group_label>15 mg THC</arm_group_label>
    <arm_group_label>7.5 mg THC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)&#xD;
&#xD;
          2. BMI 19-26&#xD;
&#xD;
          3. High school education, fluent in English&#xD;
&#xD;
          4. Experienced non-daily marijuana users&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
          5. Current drug/alcohol abuse or dependence&#xD;
&#xD;
          6. Past year drug/alcohol dependence&#xD;
&#xD;
          7. Diagnosis with drug treatment for psychosis/bipolar/schizophrenia&#xD;
&#xD;
          8. Past year major depression&#xD;
&#xD;
          9. Panic/anxiety attacks in past 2 months&#xD;
&#xD;
         10. PTSD&#xD;
&#xD;
         11. ADHD&#xD;
&#xD;
         12. Cardiovascular illness, high blood pressure, abnormal EKG&#xD;
&#xD;
         13. Current medications&#xD;
&#xD;
         14. Pregnant or planning to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa Pabon</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dronabinol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 6, 2022</submitted>
    <returned>March 17, 2023</returned>
  </pending_results>
  <!-- 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/NCT03804840
org study id: AIS
nct id: NCT03804840
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly
      common as states remove restrictions on use. The increased use raises new concern about the
      safety of this drug, including its ability to impair basic cognitive and psychomotor tasks,
      and whether the users are aware of their impairment. We propose to design a simple
      performance test that users can use in the field, using a cell phone, to assess their level
      of impairment relative to their own drug-free state. In this preliminary study, we will
      compare participants' simple task performance after a known dose of
      delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions.
      In our app the participants will be asked to gauge their own perceived level of impairment
      (as determined by self-ratings and judgments of impairment) as well as their actual
      impairment (as gauged by the app), providing important feedback and training about their
      ability to detect impairment.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Simple Reaction Time
time frame: Assessed two hour post intervention at peak effects
description: In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: 7.5 mg THC
arm group type: Active Comparator
arm group label: 15 mg THC
arm group type: Active Comparator
intervention type: Drug
intervention name: Dronabinol
description: THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).
arm group label: 15 mg THC
arm group label: 7.5 mg THC
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elisa Pabon
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Dronabinol
sharing ipd: No
submitted: June 6, 2022
returned: March 17, 2023