<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/NCT02193269</url>
  </required_header>
  <id_info>
    <org_study_id>1304011871</org_study_id>
    <nct_id>NCT02193269</nct_id>
  </id_info>
  <brief_title>The Effects of Minocycline in Humans</brief_title>
  <official_title>Cognitive Effects of Minocycline in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine minocycline's effects on cognitive performance and measures of mood in abstinent&#xD;
      cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits&#xD;
      microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric&#xD;
      oxide (NO) production. Previous animal and human studies suggest that minocycline may have&#xD;
      utility as a treatment for cocaine addiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are proposing a randomized, double-blind, crossover study. A total of 40 male and or&#xD;
      female subject completers will have two 4-day treatment periods, in which they will be&#xD;
      randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment&#xD;
      period, subjects will have daily clinic visits for medication administration and monitoring&#xD;
      of adverse events. On Day 4, subjects will have an experimental session in which measures of&#xD;
      mood and cognitive performance will be obtained. Following a washout period, ranging from 5&#xD;
      to 15 days, subjects will be crossed over to the alternative treatment.&#xD;
&#xD;
      This study began July 2013; currently 7 subjects were randomized with 5 completers and two&#xD;
      drop outs. This study is in data analysis phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2013</start_date>
  <completion_date type="Actual">November 5, 2015</completion_date>
  <primary_completion_date type="Actual">November 5, 2015</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rapid Visual information Processing</measure>
    <time_frame>2 yrs</time_frame>
    <description>Cognitive Test to determine the speed of Visual information</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Memory Impairment</condition>
  <arm_group>
    <arm_group_label>sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.0mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minocycline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugar pill</intervention_name>
    <description>you will receive 0.0 mg as a single daily dose for 4 days</description>
    <arm_group_label>Minocycline</arm_group_label>
    <other_name>sugar pill, placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <description>you will receive 200 mg as a single daily dose for 4 days</description>
    <arm_group_label>sugar pill</arm_group_label>
    <other_name>tetracycline antibiotic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine&#xD;
             dependence according to DSM-IV criteria;&#xD;
&#xD;
          -  No cocaine use for the past 30 days;&#xD;
&#xD;
          -  No other current dependence or abuse of other drugs of abuse or alcohol (except&#xD;
             cocaine and tobacco);&#xD;
&#xD;
          -  No current medical problems and normal ECG;&#xD;
&#xD;
          -  For women, not pregnant as determined by pregnancy screening nor breast feeding, and&#xD;
             using acceptable birth control methods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current major psychiatric illnesses including mood, psychotic, or anxiety disorders;&#xD;
&#xD;
          -  history of major medical illnesses; including liver diseases, heart disease, or other&#xD;
             medical conditions that the physician investigator deems contraindicated for the&#xD;
             subject to be in the study&#xD;
&#xD;
          -  Current use of over-the-counter or prescription psychoactive drugs (antidepressant,&#xD;
             anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would&#xD;
             be expected to have major interactions with drugs to be tested, e.g., benzodiazepines,&#xD;
             codeine, percocet, and other opiate drugs that will interact with methadone.&#xD;
&#xD;
          -  Liver function tests (ALT or AST) greater than 3 times normal.&#xD;
&#xD;
          -  Allergy to minocycline or other tetracyclines.&#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>Mehmet Sofuoglu, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Veteran Affairs Hospital</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>September 2019</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Mehmet Sofuoglu</investigator_full_name>
    <investigator_title>Mehmet Sofuoglu, M.D.,Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Abstinent cocaine users</keyword>
  <keyword>minocycline</keyword>
  <keyword>antibiotic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Minocycline</mesh_term>
    <mesh_term>Tetracycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02193269
org study id: 1304011871
nct id: NCT02193269
lead sponsor: 
has dmc: Yes
To determine minocycline's effects on cognitive performance and measures of mood in abstinent
      cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits
      microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric
      oxide (NO) production. Previous animal and human studies suggest that minocycline may have
      utility as a treatment for cocaine addiction.
We are proposing a randomized, double-blind, crossover study. A total of 40 male and or
      female subject completers will have two 4-day treatment periods, in which they will be
      randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment
      period, subjects will have daily clinic visits for medication administration and monitoring
      of adverse events. On Day 4, subjects will have an experimental session in which measures of
      mood and cognitive performance will be obtained. Following a washout period, ranging from 5
      to 15 days, subjects will be crossed over to the alternative treatment.

      This study began July 2013; currently 7 subjects were randomized with 5 completers and two
      drop outs. This study is in data analysis phase.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Rapid Visual information Processing
time frame: 2 yrs
description: Cognitive Test to determine the speed of Visual information
arm group label: sugar pill
arm group type: Placebo Comparator
description: 0.0mg
arm group label: Minocycline
arm group type: Active Comparator
description: 200mg
intervention type: Drug
intervention name: Sugar pill
description: you will receive 0.0 mg as a single daily dose for 4 days
arm group label: Minocycline
other name: sugar pill, placebo
intervention type: Drug
intervention name: Minocycline
description: you will receive 200 mg as a single daily dose for 4 days
arm group label: sugar pill
other name: tetracycline antibiotic
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mehmet Sofuoglu, M.D.,Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Mehmet Sofuoglu
investigator title: Mehmet Sofuoglu, M.D.,Ph.D.
mesh term: Anti-Bacterial Agents
mesh term: Minocycline
mesh term: Tetracycline
sharing ipd: No