xml: <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/NCT06017622</url>
    </required_header>
    <id_info>
      <org_study_id>AN01AC01</org_study_id>
      <nct_id>NCT06017622</nct_id>
    </id_info>
    <brief_title>Observational Study of THC Concentrations in Acute Cannabinoid Intoxication</brief_title>
    <official_title>Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Subjects Visiting Emergency Departments for Acute Cannabinoid Intoxication</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Anebulo Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Anebulo Pharmaceuticals</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This observational study is being conducted to determine plasma concentrations of&#xD;
        tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of subjects&#xD;
        who visit the emergency department due to acute cannabinoid intoxication.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, prospective, cross-sectional observational study to determine the&#xD;
        concentrations of tetrahydrocannabinol (THC) and its metabolites (and/or other cannabinoids)&#xD;
        in the plasma of subjects admitted to emergency departments with acute cannabinoid&#xD;
        intoxication The study will explore the relationships between these concentrations and&#xD;
        parameters such as demographics, symptom severity, time to symptom resolution, and clinical&#xD;
        outcomes.&#xD;
  &#xD;
        Samples will be collected as part of standard clinical procedure without requiring study&#xD;
        participants to spend additional time in the hospital.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma Concentration of delta-9 tetrahydrocannabinol (THC)</measure>
      <time_frame>Day 1</time_frame>
      <description>Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabinoid intoxication.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Acute Cannabinoid Intoxication</condition>
    <arm_group>
      <arm_group_label>All subjects</arm_group_label>
      <description>There is a single group consisting of all subjects who meet the eligibility criteria</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples for measurement of cannabinoid and metabolite concentrations in plasma.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of patients of any age and sex who present to an&#xD;
          emergency department with acute cannabinoid intoxication.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject visits emergency department for acute cannabinoid intoxication as evidenced by&#xD;
               the following criteria:&#xD;
  &#xD;
                 1. Recent cannabis use within the last 12 hours&#xD;
  &#xD;
                 2. Clinically significant physiological abnormalities associated with cannabis use&#xD;
                    or problematic behavioral or psychological changes (e.g., altered perception,&#xD;
                    impaired motor coordination, euphoria, anxiety, a sensation of slowed time,&#xD;
                    impaired judgment, social withdrawal) that developed during, or shortly after,&#xD;
                    cannabis use&#xD;
  &#xD;
            2. Subject (and/or parent/LAR when required) has the ability to communicate with&#xD;
               comprehension with the study personnel at the time of consent/assent and the gathering&#xD;
               of data other than plasma samples.&#xD;
  &#xD;
            3. Subject (and/or parent/LAR when required) is willing and able to provide informed&#xD;
               consent/assent.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
          A potential subject who meets any of the following criteria will be excluded from&#xD;
          participation in this study:&#xD;
  &#xD;
            1. Anything that would place the individual at increased risk or preclude the&#xD;
               individual's full compliance with or completion of the study.&#xD;
  &#xD;
            2. Individuals under the age of 18 who do not have a parent or legal representative&#xD;
               present during the time at the ED.&#xD;
  &#xD;
            3. Patients presenting with signs or symptoms attributable to another medical condition&#xD;
               or better explained by another mental disorder.&#xD;
  &#xD;
            4. Patient presenting with cannabis hyperemesis syndrome (CHS) or cannabis withdrawal&#xD;
               syndrome (CWS)&#xD;
  &#xD;
            5. Patients who are brought in by law enforcement, i.e., cannabis intoxication associated&#xD;
               with a vehicle accident (driving under the influence).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ken Cundy, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Anebulo Pharmaceuticals Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Linda Klumpers, PhD</last_name>
      <phone>512-598-0931</phone>
      <email>linda@anebulo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ken Cundy, PhD</last_name>
      <phone>512-598-0931</phone>
      <email>ken@anebulo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Colorado School of Medicine</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrew Monte, MD, PhD</last_name>
        <phone>720-848-0000</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Vermont Medical Center</name>
        <address>
          <city>Burlington</city>
          <state>Vermont</state>
          <zip>05401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Kalev Freeman, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017622
  org study id: AN01AC01
  nct id: NCT06017622
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study is being conducted to determine plasma concentrations of
        tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of subjects
        who visit the emergency department due to acute cannabinoid intoxication.
  This is a multi-center, prospective, cross-sectional observational study to determine the
        concentrations of tetrahydrocannabinol (THC) and its metabolites (and/or other cannabinoids)
        in the plasma of subjects admitted to emergency departments with acute cannabinoid
        intoxication The study will explore the relationships between these concentrations and
        parameters such as demographics, symptom severity, time to symptom resolution, and clinical
        outcomes.
  
        Samples will be collected as part of standard clinical procedure without requiring study
        participants to spend additional time in the hospital.
  observational model: Cohort
  time perspective: Prospective
  measure: Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
  time frame: Day 1
  description: Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabinoid intoxication.
  arm group label: All subjects
  description: There is a single group consisting of all subjects who meet the eligibility criteria
  Blood samples for measurement of cannabinoid and metabolite concentrations in plasma.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Ken Cundy, PhD
  role: Study Director
  affiliation: Anebulo Pharmaceuticals Inc.
  last name: Linda Klumpers, PhD
  phone: 512-598-0931
  email: linda@anebulo.com
  last name: Ken Cundy, PhD
  phone: 512-598-0931
  email: ken@anebulo.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No