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/NCT06029296</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00107035</org_study_id>
      <nct_id>NCT06029296</nct_id>
    </id_info>
    <brief_title>Diclofenac as a KMO Inhibitor</brief_title>
    <acronym>DKMOI</acronym>
    <official_title>Proof of Concept: Diclofenac as a KMO Inhibitor in Individuals With Alcohol Use Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Maryland, Baltimore</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>
        This mechanistic, proof of concept laboratory study will test the pharmacological properties&#xD;
        of diclofenac in individuals with AUD. Participants will complete two sessions in which they&#xD;
        will receive a single dose of diclofenac (100 mg) or matched placebo in a randomized and&#xD;
        double blind fashion. The primary aim is to assess whether this dose of diclofenac, vs.&#xD;
        placebo, increases circulating levels of kynurenic acid. This finding would provide evidence&#xD;
        that diclofenac (100 mg) inhibits the kynurenine 3-monooxygenase enzyme.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Kynurenic Acid</measure>
      <time_frame>0-, 60-, 120-, 180-, and 240-minutes after pill administration</time_frame>
      <description>Serum levels of Kynurenic Acid</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <arm_group>
      <arm_group_label>Diclofenac</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will take a single 100mg dose of diclofenac.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will take a single dose of placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Diclofenac</intervention_name>
      <description>100 mg</description>
      <arm_group_label>Diclofenac</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Sugar pill</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 21-65&#xD;
  &#xD;
            -  Meet DSM-5 diagnostic criteria for AUD of any severity (Mild, Moderate, or Severe)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders and&#xD;
               bipolar and related disorders&#xD;
  &#xD;
            -  Positive urine toxicology screen for the following substances: cocaine, opiates,&#xD;
               amphetamines, methamphetamine, phencyclidine, barbiturates, benzodiazepine, methadone,&#xD;
               and tricyclic antidepressants&#xD;
  &#xD;
            -  Self-reported daily use of opioids (including prescribed)&#xD;
  &#xD;
            -  Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical&#xD;
               Institute Withdrawal Assessment for Alcohol-Revised&#xD;
  &#xD;
            -  If female: pregnant, nursing, or with reproductive potential who refuses to use&#xD;
               reliable methods of birth control throughout the study&#xD;
  &#xD;
            -  Any autoimmune disorder, inflammatory disorder, or medical condition that may&#xD;
               interfere with safe study participation and/or study aims (e.g., any cardiac, renal,&#xD;
               or liver disease, uncontrolled hypertension, or diabetes)&#xD;
  &#xD;
            -  Attempted suicide in the past 3 years and/or serious suicidal intention or plan within&#xD;
               the past year&#xD;
  &#xD;
            -  Currently on prescription medication that contraindicates use of diclofenac, including&#xD;
               but not necessarily limited to: oral corticosteroids, anticoagulants, lithium,&#xD;
               warfarin, aspirin (daily use), methotrexate, cyclosporine, ACE-inhibitors, and&#xD;
               diuretics like furosemide and thiazides&#xD;
  &#xD;
            -  Previously known hypersensitivity, including gastroenteritis, asthma, and&#xD;
               allergic-type reactions, to any NSAID and/or aspirin&#xD;
  &#xD;
            -  Current daily use of any NSAID or regular pattern of near daily use within the past&#xD;
               three months, regular use of a prebiotic or probiotic supplement and/or any&#xD;
               antibiotic, prebiotic, or probiotic use within the last month&#xD;
  &#xD;
            -  Any lifetime history of ulcer disease, gastritis, gastroenteritis, or gastrointestinal&#xD;
               bleeding&#xD;
  &#xD;
            -  Current or recent (within 3 months) participation in a clinical trial involving&#xD;
               medication administration&#xD;
  &#xD;
            -  Currently in treatment, a history of treatment within the 30 days before enrollment,&#xD;
               or currently seeking immediate treatment for AUD&#xD;
  &#xD;
            -  Current (last 12 months) DSM-5 diagnosis of SUD for any psychoactive substances other&#xD;
               than alcohol and nicotine&#xD;
  &#xD;
            -  Currently prescribed a psychotropic medication for the treatment of schizophrenia&#xD;
               spectrum and other psychotic disorders, bipolar and related disorders&#xD;
  &#xD;
            -  AST and ALT &gt; four times the upper limit of the normal range, or albumin, GFR, BUN, or&#xD;
               creatinine 15% &gt; the upper limit of the normal range&#xD;
  &#xD;
            -  Suffered a mild or moderate traumatic brain injury (TBI) within the last 12 months, a&#xD;
               severe TBI at any point in their life, or a moderate TBI before the age of 12&#xD;
  &#xD;
            -  Has below a 6th grade reading level&#xD;
  &#xD;
            -  Within the last 3 months, tested positive for COVID-19 (i.e. the SARS-CoV-2 virus) and&#xD;
               experienced common related symptoms&#xD;
  &#xD;
            -  Any other circumstances that, in the opinion of the investigators, compromises&#xD;
               participant safety, ability of the investigators to conduct the study as designed,&#xD;
               and/or study integrity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Roche, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brian Brandler, MA</last_name>
      <phone>410-402-6425</phone>
      <email>bbrandler@som.umaryland.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>AnneMarie Kearns, BS</last_name>
      <phone>410-402-6854</phone>
      <email>akearns@mprc.umaryland.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)</name>
        <address>
          <city>Catonsville</city>
          <state>Maryland</state>
          <zip>21228</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Brian Brandler, MA</last_name>
        <phone>410-402-6425</phone>
        <email>bbrandler@som.umaryland.edu</email>
      </contact>
      <investigator>
        <last_name>Daniel Roche, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diclofenac</keyword>
    <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>Diclofenac</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/NCT06029296
  org study id: HP-00107035
  nct id: NCT06029296
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This mechanistic, proof of concept laboratory study will test the pharmacological properties
        of diclofenac in individuals with AUD. Participants will complete two sessions in which they
        will receive a single dose of diclofenac (100 mg) or matched placebo in a randomized and
        double blind fashion. The primary aim is to assess whether this dose of diclofenac, vs.
        placebo, increases circulating levels of kynurenic acid. This finding would provide evidence
        that diclofenac (100 mg) inhibits the kynurenine 3-monooxygenase enzyme.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Kynurenic Acid
  time frame: 0-, 60-, 120-, 180-, and 240-minutes after pill administration
  description: Serum levels of Kynurenic Acid
  arm group label: Diclofenac
  arm group type: Active Comparator
  description: Participants will take a single 100mg dose of diclofenac.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will take a single dose of placebo.
  intervention type: Drug
  intervention name: Diclofenac
  description: 100 mg
  arm group label: Diclofenac
  intervention type: Drug
  intervention name: Placebo
  description: Sugar pill
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Daniel Roche, PhD
  role: Principal Investigator
  affiliation: University of Maryland School of Medicine
  last name: Brian Brandler, MA
  phone: 410-402-6425
  email: bbrandler@som.umaryland.edu
  last name: AnneMarie Kearns, BS
  phone: 410-402-6854
  email: akearns@mprc.umaryland.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alcoholism
  mesh term: Alcohol Drinking
  mesh term: Diclofenac
  sharing ipd: No