<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/NCT03256253</url>
  </required_header>
  <id_info>
    <org_study_id>7491</org_study_id>
    <nct_id>NCT03256253</nct_id>
  </id_info>
  <brief_title>Pregabalin as Treatment for Alcohol Use Disorder</brief_title>
  <official_title>An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</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>
      The proposed protocol is an 8 week open label outpatient pilot trial of the safety and&#xD;
      efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary&#xD;
      objective of the study is to determine the efficacy of pregabalin in promoting alcohol&#xD;
      abstinence among individuals with an alcohol use disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of&#xD;
      pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for&#xD;
      the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve&#xD;
      pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in&#xD;
      an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in&#xD;
      outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to&#xD;
      determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with&#xD;
      an alcohol use disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>Phase 2</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>open label pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Dose of Pregabalin:</measure>
    <time_frame>over the course of the 8 week trial or participants' length of participation</time_frame>
    <description>Defined as the highest amount of medication per day maintained for a 7 day period.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pregabalin up to daily dose of 600 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>pregabalin up to 600 mg/day</description>
    <arm_group_label>pregabalin</arm_group_label>
    <other_name>lyrica</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets DSM-5 criteria for current alcohol use disorder&#xD;
&#xD;
          -  Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women&#xD;
             at least 4 days per week over the past 28 days&#xD;
&#xD;
          -  Between the ages of 18 and 65&#xD;
&#xD;
          -  Able to provide informed consent and comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD,&#xD;
             that in the investigator's judgment might require intervention over the course of the&#xD;
             study.&#xD;
&#xD;
          -  Subjects receiving psychotropic medication treatment&#xD;
&#xD;
          -  Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar &gt; 13)&#xD;
&#xD;
          -  History of alcohol withdrawal seizures or alcohol withdrawal delirium&#xD;
&#xD;
          -  History of allergic reaction to candidate medication (pregabalin)&#xD;
&#xD;
          -  Pregnancy, lactation, or failure in females patients to use adequate contraceptive&#xD;
             methods&#xD;
&#xD;
          -  Unstable physical disorders which might make participation hazardous&#xD;
&#xD;
          -  Subjects who have a current DSM-5 diagnosis of moderate or severe substance use&#xD;
             disorder, with the exception of alcohol, nicotine and caffeine use disorders. A&#xD;
             diagnosis of a mild substance use disorder will not be exclusionary, as long as the&#xD;
             current primary substance use disorder is alcohol.&#xD;
&#xD;
          -  Are legally mandated to participate in alcohol use disorder treatment program&#xD;
&#xD;
          -  Cognitively impaired&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>john mariani, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>new york psychiatric institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia Univeristy-STARS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>July 21, 2020</results_first_submitted>
  <results_first_submitted_qc>July 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2020</results_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>John Mariani MD</investigator_full_name>
    <investigator_title>Research psychiatrist</investigator_title>
  </responsible_party>
  <keyword>alcohol use disorder</keyword>
  <keyword>alcohol abuse</keyword>
  <keyword>treatment</keyword>
  <keyword>lyrica</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>Pregabalin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03256253/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03256253/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pregabalin</title>
          <description>pregabalin up to daily dose of 600 mg&#xD;
Pregabalin: pregabalin up to 600 mg/day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pregabalin</title>
          <description>pregabalin up to daily dose of 600 mg&#xD;
Pregabalin: pregabalin up to 600 mg/day</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.1" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Dose of Pregabalin:</title>
        <description>Defined as the highest amount of medication per day maintained for a 7 day period.</description>
        <time_frame>over the course of the 8 week trial or participants' length of participation</time_frame>
        <population>Data was available for 14 patients</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>pregabalin up to daily dose of 600 mg&#xD;
Pregabalin: pregabalin up to 600 mg/day</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Dose of Pregabalin:</title>
          <description>Defined as the highest amount of medication per day maintained for a 7 day period.</description>
          <population>Data was available for 14 patients</population>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="571.4" spread="80.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over the course of the 8 week trial or length of participant's participation</time_frame>
      <desc>Data was collected for 15 participants with post-enrollment data</desc>
      <group_list>
        <group group_id="E1">
          <title>Pregabalin</title>
          <description>pregabalin up to daily dose of 600 mg&#xD;
Pregabalin: pregabalin up to 600 mg/day</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>blurred vision</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>eye redness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>drowsiness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>fogginess</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>vivid dreams</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>dry mouth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>difficulty concentrating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>dry eyes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>increased sensitivity to alcohol</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>swollen feet</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Mariani MD</name_or_title>
      <organization>New York State Psychiatric Institute</organization>
      <phone>6467748181</phone>
      <email>john.mariani@nyspi.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03256253
org study id: 7491
nct id: NCT03256253
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and
      efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary
      objective of the study is to determine the efficacy of pregabalin in promoting alcohol
      abstinence among individuals with an alcohol use disorder.
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of
      pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for
      the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve
      pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in
      an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in
      outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to
      determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with
      an alcohol use disorder.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open label pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Dose of Pregabalin:
time frame: over the course of the 8 week trial or participants' length of participation
description: Defined as the highest amount of medication per day maintained for a 7 day period.
arm group label: pregabalin
arm group type: Experimental
description: pregabalin up to daily dose of 600 mg
intervention type: Drug
intervention name: Pregabalin
description: pregabalin up to 600 mg/day
arm group label: pregabalin
other name: lyrica
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: john mariani, md
role: Principal Investigator
affiliation: new york psychiatric institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: John Mariani MD
investigator title: Research psychiatrist
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Pregabalin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 