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/NCT05995769</url>
    </required_header>
    <id_info>
      <org_study_id>REB23-0666</org_study_id>
      <nct_id>NCT05995769</nct_id>
    </id_info>
    <brief_title>Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder</brief_title>
    <acronym>PAP-AUD</acronym>
    <official_title>Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Calgary</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Maryland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bloom Psychedelic Therapy and Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Calgary</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The aim of this study is to determine if a single dose of psilocybin administered with&#xD;
        motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol&#xD;
        use disorder (AUD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of this study is to determine if psilocybin administered with a&#xD;
        standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can&#xD;
        reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients&#xD;
        with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a&#xD;
        low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of&#xD;
        MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking&#xD;
        days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.&#xD;
  &#xD;
        A total of 128 male and female patients between the ages of 22-65 with a moderate to severe&#xD;
        AUD diagnosis will be recruited from the community. Participants will undergo a thorough&#xD;
        screening procedure and eligible participants will be randomly allocated to the high (N=64)&#xD;
        or low (N=64) psilocybin doses. All participants will complete a baseline session consisting&#xD;
        of clinical, behavioral, and neuroimaging measures. Following the single dosing session,&#xD;
        participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed&#xD;
        again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and&#xD;
        12-weeks post-dosing&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2027</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heavy drinking</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>Percent heavy drinking days (TLFB)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Abstinence</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>Days abstinent (TLFB)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers of alcohol consumption</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>Phosphatidylethanol (Peth)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alcohol cue reactivity</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>Alcohol urge questionnaire (AUQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive flexibility</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>Berg Card Sorting Task</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>The Montgomery-Åsberg Depression Rating Scale (MADRS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>The General Anxiety Disorder 7 (GAD-7) scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life</measure>
      <time_frame>Change from baseline to 1-, 4-, and 12-weeks post-dosing</time_frame>
      <description>The World Health Organization Quality of Life (WHOQOL) scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glutamate levels</measure>
      <time_frame>Change from baseline to 1-week post-dosing</time_frame>
      <description>MR spectroscopy of glutamate levels in the anterior cingulate cortex</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GABA levels</measure>
      <time_frame>Change from baseline to 1-week post-dosing</time_frame>
      <description>MR spectroscopy of GABA levels in the anterior cingulate cortex</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resting state functional connectivity</measure>
      <time_frame>Change from baseline to 1-week post-dosing</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <condition>Alcoholism</condition>
    <arm_group>
      <arm_group_label>High Dose (25mg)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose (1mg)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Psilocybin</intervention_name>
      <description>Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing</description>
      <arm_group_label>High Dose (25mg)</arm_group_label>
      <arm_group_label>Low dose (1mg)</arm_group_label>
      <other_name>magic mushrooms</other_name>
      <other_name>PEX010</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meets DSM-5 AUD criteria of at least moderate severity&#xD;
  &#xD;
            -  At least 5 heavy drinking days in past 30 days&#xD;
  &#xD;
            -  At least 18 (females) or 24 (males) drinks per week in past 30 days&#xD;
  &#xD;
            -  Desire to decrease alcohol consumption&#xD;
  &#xD;
            -  Limited lifetime hallucinogen use (less than 10 times total, none in past 6 months)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe or moderate substance use disorder other than alcohol or nicotine in past 6&#xD;
               months&#xD;
  &#xD;
            -  Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis&#xD;
  &#xD;
            -  Active suicidal ideation or serious attempt within past 3 years&#xD;
  &#xD;
            -  Currently pregnant, nursing, or trying to become pregnant&#xD;
  &#xD;
            -  Any notable abnormality on ECG, physical exam, or routine medical blood laboratory&#xD;
               test&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leah Mayo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Calgary</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kaitlin O'Grady</last_name>
      <phone>587-893-0257</phone>
      <email>pactlab@ucalgary.ca</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Alcoholism</mesh_term>
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psilocybin</mesh_term>
    </intervention_browse>
    <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/NCT05995769
  org study id: REB23-0666
  nct id: NCT05995769
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The aim of this study is to determine if a single dose of psilocybin administered with
        motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol
        use disorder (AUD).
  The primary objective of this study is to determine if psilocybin administered with a
        standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can
        reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients
        with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a
        low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of
        MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking
        days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.
  
        A total of 128 male and female patients between the ages of 22-65 with a moderate to severe
        AUD diagnosis will be recruited from the community. Participants will undergo a thorough
        screening procedure and eligible participants will be randomly allocated to the high (N=64)
        or low (N=64) psilocybin doses. All participants will complete a baseline session consisting
        of clinical, behavioral, and neuroimaging measures. Following the single dosing session,
        participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed
        again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and
        12-weeks post-dosing
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Heavy drinking
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: Percent heavy drinking days (TLFB)
  measure: Abstinence
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: Days abstinent (TLFB)
  measure: Biomarkers of alcohol consumption
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: Phosphatidylethanol (Peth)
  measure: Alcohol cue reactivity
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: Alcohol urge questionnaire (AUQ)
  measure: Cognitive flexibility
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: Berg Card Sorting Task
  measure: Depression
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: The Montgomery-Åsberg Depression Rating Scale (MADRS)
  measure: Anxiety
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: The General Anxiety Disorder 7 (GAD-7) scale
  measure: Quality of life
  time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
  description: The World Health Organization Quality of Life (WHOQOL) scale
  measure: Glutamate levels
  time frame: Change from baseline to 1-week post-dosing
  description: MR spectroscopy of glutamate levels in the anterior cingulate cortex
  measure: GABA levels
  time frame: Change from baseline to 1-week post-dosing
  description: MR spectroscopy of GABA levels in the anterior cingulate cortex
  measure: Resting state functional connectivity
  time frame: Change from baseline to 1-week post-dosing
  arm group label: High Dose (25mg)
  arm group type: Experimental
  description: PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
  arm group label: Low dose (1mg)
  arm group type: Active Comparator
  description: PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
  intervention type: Drug
  intervention name: Psilocybin
  description: Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
  arm group label: High Dose (25mg)
  arm group label: Low dose (1mg)
  other name: magic mushrooms
  other name: PEX010
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Leah Mayo, PhD
  role: Principal Investigator
  affiliation: University of Calgary
  last name: Kaitlin O'Grady
  phone: 587-893-0257
  email: pactlab@ucalgary.ca
  responsible party type: Sponsor
  mesh term: Alcoholism
  mesh term: Alcohol Drinking
  mesh term: Psilocybin
  sharing ipd: No