<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/NCT02205879</url>
  </required_header>
  <id_info>
    <org_study_id>BRPI-PGBL-A01</org_study_id>
    <nct_id>NCT02205879</nct_id>
  </id_info>
  <brief_title>Pregabalin for Alcohol Dependence</brief_title>
  <official_title>Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Petersburg Bekhterev Research Psychoneurological Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Petersburg Bekhterev Research Psychoneurological Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking&#xD;
      and reducing drinking severity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two cell double blind placebo controlled randomized clinical trial of pregabalin&#xD;
      for alcohol dependence&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 4</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>Retention in treatment</measure>
    <time_frame>three months</time_frame>
    <description>Number of subjects retianed in treatment (not relapsed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weekly alcohol consumption</measure>
    <time_frame>three months</time_frame>
    <description>Time Line Follow Back technique</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>three months</time_frame>
    <description>Hamilton anxiety scale and Spielbereger State Trait Anxiety test</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <arm_group_label>pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alcohol Dependence by ICD-X criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe co-morbid psychiatric and somatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St.-Petersburg Bekhterev Reserach Psychoneurological Institute</name>
      <address>
        <city>St.-Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregabalin</keyword>
  <keyword>patients</keyword>
  <keyword>treatment</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>Pregabalin</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/NCT02205879
org study id: BRPI-PGBL-A01
nct id: NCT02205879
lead sponsor: 
collaborator: 
has dmc: No
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking
      and reducing drinking severity
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin
      for alcohol dependence
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Retention in treatment
time frame: three months
description: Number of subjects retianed in treatment (not relapsed)
measure: Weekly alcohol consumption
time frame: three months
description: Time Line Follow Back technique
measure: Anxiety
time frame: three months
description: Hamilton anxiety scale and Spielbereger State Trait Anxiety test
arm group label: pregabalin
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pregabalin
arm group label: pregabalin
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Pregabalin