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/NCT06004830</url>
    </required_header>
    <id_info>
      <org_study_id>2000033919_a</org_study_id>
      <secondary_id>1P01AA029545-01</secondary_id>
      <nct_id>NCT06004830</nct_id>
    </id_info>
    <brief_title>Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1</brief_title>
    <acronym>HARP</acronym>
    <official_title>Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</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 study seeks to determine the feasibility, acceptability, and preliminary efficacy of an&#xD;
        intervention consisting of off-label use of a medication with strong efficacy data for&#xD;
        alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered&#xD;
        behavioral intervention in reducing alcohol use among individuals with HIV and AUD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a series of three open-label pilot studies that consist of a 12-week intervention&#xD;
        including off-label use of medication with MM and a clinical pharmacist-delivered behavioral&#xD;
        intervention to treat AUD. Participants will receive counseling that incorporates brief&#xD;
        feedback and advice with motivational enhancement techniques to assist the participant in&#xD;
        changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as&#xD;
        taking five or more medications, particularly if those medications interact with alcohol. In&#xD;
        addition, participants will be offered varenicline in the first pilot study. The rationale&#xD;
        for utilizing an open-label pilot study design is to determine the feasibility,&#xD;
        acceptability, safety, and preliminary efficacy of this intervention for the management of&#xD;
        AUD. Participants will be interviewed with regards to their perspectives on feasibility and&#xD;
        acceptability. They will be instructed to have medication bottles at study visits to assess&#xD;
        medication adherence and will be assessed with readiness to change metrics and questions&#xD;
        regarding quantity and frequency of alcohol use. Patients will also be asked to complete an&#xD;
        AUDIT-C screen and if score &gt;/=7, the Alcohol Symptom Checklist at the start of the study&#xD;
        period. Several assessments including interviews and laboratory testing will be done at study&#xD;
        visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Single arm</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants who complete enrollment and duration of sessions</measure>
      <time_frame>12 weeks</time_frame>
      <description>Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of sessions completed</measure>
      <time_frame>12 weeks</time_frame>
      <description>Number of sessions completed to assess acceptability of study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to Medication</measure>
      <time_frame>12 weeks</time_frame>
      <description>Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety of study assessed by adverse events reporting</measure>
      <time_frame>12 weeks</time_frame>
      <description>Safety will be assessed by the percentage of study participants who report adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of study - change in self-reported alcohol use</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of study - change in PEth (phosphatidylethanol) results</measure>
      <time_frame>12 weeks</time_frame>
      <description>PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <condition>Hiv</condition>
    <arm_group>
      <arm_group_label>Spironolactone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a prescription for spironolactone</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Spironolactone</intervention_name>
      <description>All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support</description>
      <arm_group_label>Spironolactone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with HIV&#xD;
  &#xD;
            -  Receive care at the Atlanta VA Healthcare System&#xD;
  &#xD;
            -  Age 18 or over&#xD;
  &#xD;
            -  Meet criteria for moderate to severe alcohol use disorder by the DSM-5 Alcohol Symptom&#xD;
               Checklist&#xD;
  &#xD;
            -  Score &gt;7 on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen&#xD;
  &#xD;
            -  Have evidence of significant alcohol use: PEth &gt; 20ng/ml&#xD;
  &#xD;
            -  Prescribed &gt;=5 medications&#xD;
  &#xD;
            -  Have cell phone or reliable contact number&#xD;
  &#xD;
            -  Can provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active engagement in formal alcohol treatment including medications for alcohol use&#xD;
               disorder at the time of enrollment&#xD;
  &#xD;
            -  Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive&#xD;
  &#xD;
            -  Life-threatening or unstable medical, surgical, or psychiatric condition that&#xD;
               prohibits participation (including current or past intent to harm oneself or others&#xD;
               within the prior 12 months and not receiving treatment&#xD;
  &#xD;
            -  Untreated moderate to severe opioid use disorder&#xD;
  &#xD;
            -  Residence out of state&#xD;
  &#xD;
            -  Inability to read or understand English&#xD;
  &#xD;
            -  History of serious hypersensitivity or adverse reaction to study medication&#xD;
  &#xD;
            -  Taking potentially interactive medication(s): eplerenone, potassium supplementation,&#xD;
               lithium, digoxin, cholestyramine, heparin and low-molecular weight heparin for&#xD;
               spironolactone)&#xD;
  &#xD;
            -  Hyperkalemia defined as serum potassium ≥ 5.0 mEq/L on the most recent laboratory test&#xD;
               performed in the past 60 days prior to enrollment or Addison's disease or estimated&#xD;
               glomerular filtration rate &lt;50 mL/min/1.73 m2 (for spironolactone)&#xD;
  &#xD;
            -  Creatinine level of ≥1.5 mg/dl (for spironolactone)&#xD;
  &#xD;
            -  Already prescribed the pilot medication at the time of study recruitment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>E. Jennifer Edelman, MD, MHS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>E. Jennifer Edelman, MD, MHS</last_name>
      <phone>203-737-7115</phone>
      <email>ejennifer.edelman@yale.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>June-Marie Weiss, MA, MEd</last_name>
      <phone>203-737-3347</phone>
      <email>junemarie.weiss@yale.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 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>Spironolactone</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06004830
  org study id: 2000033919_a
  secondary id: 1P01AA029545-01
  nct id: NCT06004830
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an
        intervention consisting of off-label use of a medication with strong efficacy data for
        alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered
        behavioral intervention in reducing alcohol use among individuals with HIV and AUD.
  This is a series of three open-label pilot studies that consist of a 12-week intervention
        including off-label use of medication with MM and a clinical pharmacist-delivered behavioral
        intervention to treat AUD. Participants will receive counseling that incorporates brief
        feedback and advice with motivational enhancement techniques to assist the participant in
        changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as
        taking five or more medications, particularly if those medications interact with alcohol. In
        addition, participants will be offered varenicline in the first pilot study. The rationale
        for utilizing an open-label pilot study design is to determine the feasibility,
        acceptability, safety, and preliminary efficacy of this intervention for the management of
        AUD. Participants will be interviewed with regards to their perspectives on feasibility and
        acceptability. They will be instructed to have medication bottles at study visits to assess
        medication adherence and will be assessed with readiness to change metrics and questions
        regarding quantity and frequency of alcohol use. Patients will also be asked to complete an
        AUDIT-C screen and if score >/=7, the Alcohol Symptom Checklist at the start of the study
        period. Several assessments including interviews and laboratory testing will be done at study
        visits.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single arm
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of participants who complete enrollment and duration of sessions
  time frame: 12 weeks
  description: Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study
  measure: Number of sessions completed
  time frame: 12 weeks
  description: Number of sessions completed to assess acceptability of study
  measure: Adherence to Medication
  time frame: 12 weeks
  description: Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study
  measure: Safety of study assessed by adverse events reporting
  time frame: 12 weeks
  description: Safety will be assessed by the percentage of study participants who report adverse events
  measure: Efficacy of study - change in self-reported alcohol use
  time frame: 12 weeks
  description: Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.
  measure: Efficacy of study - change in PEth (phosphatidylethanol) results
  time frame: 12 weeks
  description: PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.
  arm group label: Spironolactone
  arm group type: Experimental
  description: Participants will receive a prescription for spironolactone
  intervention type: Drug
  intervention name: Spironolactone
  description: All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support
  arm group label: Spironolactone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: E. Jennifer Edelman, MD, MHS
  role: Principal Investigator
  affiliation: Yale School of Medicine
  last name: E. Jennifer Edelman, MD, MHS
  phone: 203-737-7115
  email: ejennifer.edelman@yale.edu
  last name: June-Marie Weiss, MA, MEd
  phone: 203-737-3347
  email: junemarie.weiss@yale.edu
  responsible party type: Sponsor
  mesh term: Alcoholism
  mesh term: Alcohol Drinking
  mesh term: Spironolactone