<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/NCT02187211</url>
  </required_header>
  <id_info>
    <org_study_id>1312013129</org_study_id>
    <secondary_id>1R21AA023150-01A1</secondary_id>
    <nct_id>NCT02187211</nct_id>
  </id_info>
  <brief_title>Minocycline's Effects on Alcohol Responses in Humans</brief_title>
  <official_title>Minocycline's Effects on Alcohol Responses in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind, placebo-controlled, outpatient study with a between-groups design.&#xD;
      Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or&#xD;
      400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3&#xD;
      outpatient visits for medication administration, dispensing of take-home doses and monitoring&#xD;
      of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will&#xD;
      have 2 laboratory sessions where alcohol or placebo will be administered intravenously using&#xD;
      a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc)&#xD;
      method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple&#xD;
      outcome measures including subjective, motor, cognitive measurement and plasma cytokine&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biphasic Alcohol Effects Scale (BAES)</measure>
    <time_frame>Days 1-10</time_frame>
    <description>BAES will be used to measure the stimulant and sedative effects of alcohol during the test sessions. This instrument has been found to be a sensitive and reliable measure to study medication influences on alcohol effects</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Minocycline Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minocycline High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this arm will receive the Placebo for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <arm_group_label>Minocycline High Dose</arm_group_label>
    <arm_group_label>Minocycline Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Minocycline)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and females, between the ages of 21 and 50;&#xD;
&#xD;
          2. Heavy social drinkers who are defined as consuming ≥10 standard alcoholic drinks per&#xD;
             week with one to five weekly &quot;binge&quot; drinking episodes, (5 plus drinks per occasion&#xD;
             for men; 4 plus drinks for women). No maximum level of alcohol consumption will be&#xD;
             defined a priori but individuals who met current DSM -IV criteria for AUD will be&#xD;
             excluded from the study;&#xD;
&#xD;
          3. No current drug use disorder of any drugs of abuse (except alcohol and tobacco);&#xD;
&#xD;
          4. No current medical problems and normal ECG; 5) For women, not pregnant as determined&#xD;
             by pregnancy screening nor breast feeding, and using acceptable birth control methods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;&#xD;
&#xD;
          2. History of major medical illnesses; including liver diseases, heart disease, chronic&#xD;
             pain or other medical conditions that the physician investigator deems contraindicated&#xD;
             for the subject to be in the study;&#xD;
&#xD;
          3. Liver function tests (ALT or AST) greater than 3 times normal;&#xD;
&#xD;
          4. Allergy to minocycline or other tetracyclines;&#xD;
&#xD;
          5. Participants who at any appointment have a Clinical Institute Withdrawal Assessment&#xD;
             Scale (CIWA) [36, 37] score of 4 or greater, or who report any history of alcohol&#xD;
             withdrawal within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismene Petrakis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Dependence</keyword>
  <keyword>Minocycline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02187211
org study id: 1312013129
secondary id: 1R21AA023150-01A1
nct id: NCT02187211
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a double-blind, placebo-controlled, outpatient study with a between-groups design.
      Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or
      400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3
      outpatient visits for medication administration, dispensing of take-home doses and monitoring
      of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will
      have 2 laboratory sessions where alcohol or placebo will be administered intravenously using
      a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc)
      method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple
      outcome measures including subjective, motor, cognitive measurement and plasma cytokine
      levels.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Biphasic Alcohol Effects Scale (BAES)
time frame: Days 1-10
description: BAES will be used to measure the stimulant and sedative effects of alcohol during the test sessions. This instrument has been found to be a sensitive and reliable measure to study medication influences on alcohol effects
arm group label: Minocycline Low Dose
arm group type: Experimental
description: Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
arm group label: Minocycline High Dose
arm group type: Experimental
description: Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants in this arm will receive the Placebo for 10 days
intervention type: Drug
intervention name: Minocycline
arm group label: Minocycline High Dose
arm group label: Minocycline Low Dose
intervention type: Drug
intervention name: Placebo (for Minocycline)
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ismene Petrakis, M.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Minocycline