<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/NCT02226367</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-12-2-0094</org_study_id>
    <nct_id>NCT02226367</nct_id>
  </id_info>
  <brief_title>Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD</brief_title>
  <official_title>Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Institute for Biomedical and Clinical Research</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>VA Puget Sound Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Institute for Biomedical and Clinical Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate if the drug prazosin:&#xD;
&#xD;
        -  will decrease alcohol use in active duty members of the military who served in Iraq&#xD;
           and/or Afghanistan and&#xD;
&#xD;
        -  determine if presence or absence of posttraumatic stress disorder affects treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a 19-week, titration to stable dose, randomized, two-group&#xD;
      parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin&#xD;
      for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in&#xD;
      Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use&#xD;
      disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or&#xD;
      absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week&#xD;
      Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than&#xD;
      placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size&#xD;
      will be greater in Service Members with PTSD than without PTSD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">October 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</primary_completion_date>
  <phase>N/A</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>Change in Penn Alcohol Craving Scale Score</measure>
    <time_frame>Change at Week 13 from Baseline</time_frame>
    <description>Penn Alcohol Craving Scale (PACS)&#xD;
The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Alcohol Use Disorders</condition>
  <condition>Stress Disorders, Posttraumatic</condition>
  <condition>Combat Disorders</condition>
  <arm_group>
    <arm_group_label>prazosin hydrochloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prazosin hydrochloride</intervention_name>
    <description>study drug arm prazosin</description>
    <arm_group_label>prazosin hydrochloride</arm_group_label>
    <other_name>prazosin</other_name>
    <other_name>Pfizer Minipress</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>study drug arm placebo</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan&#xD;
             over the age of 21 with a current Diagnostic and Statistical Manual of Mental&#xD;
             Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and&#xD;
             Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder&#xD;
&#xD;
          -  Participant in Army Substance Abuse Program (6 or 12 week program)&#xD;
&#xD;
          -  Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at&#xD;
             least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the&#xD;
             past 60 day period (4 or more drinks for women and 5 or more drinks for men)&#xD;
&#xD;
          -  Good general medical health (see Exclusion Criteria below)&#xD;
&#xD;
          -  Women of childbearing potential must agree to abstain from sexual relations that could&#xD;
             result in pregnancy or use an effective method of birth control acceptable to both&#xD;
             participant and the study clinician during the study. Men are not required to use&#xD;
             contraception during the study.&#xD;
&#xD;
          -  Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to&#xD;
             Baseline&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal&#xD;
             substance dependence or abuse.&#xD;
&#xD;
          -  Signs or symptoms of alcohol withdrawal at the time of initial consent&#xD;
&#xD;
          -  Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar&#xD;
             disorder, or cognitive disorder.&#xD;
&#xD;
          -  Suicide attempt or suicidal ideation with intent in the past month.&#xD;
&#xD;
          -  Significant acute or chronic medical illness, including unstable angina, recent&#xD;
             myocardial infarction, history of congestive heart failure, preexisting hypotension&#xD;
             (systolic &lt;100) or orthostatic hypotension (defined as a systolic drop &gt; 20 mmHg after&#xD;
             two minutes standing accompanied by lightheadedness or syncope); insulin-dependent&#xD;
             diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's&#xD;
             disease. Liver function tests more than 5 times the upper limit.&#xD;
&#xD;
          -  Concomitant use of trazodone (due to increased risk of priapism). There will be a two&#xD;
             week trazodone washout period before the baseline visit.&#xD;
&#xD;
          -  Concomitant use of an alpha-1 blocker medication or insulin&#xD;
&#xD;
          -  Use of prazosin in the 4 weeks prior to Baseline.&#xD;
&#xD;
          -  History of prazosin sensitivity/allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murray Raskind, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Veterans Affairs Puget Sound Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>November 7, 2022</results_first_submitted>
  <results_first_submitted_qc>January 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2023</results_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prazosin</keyword>
  <keyword>alcohol use disorders</keyword>
  <keyword>posttraumatic stress disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>combat trauma</keyword>
  <keyword>military</keyword>
  <keyword>alpha-1 adrenoreceptor antagonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
    <mesh_term>Combat Disorders</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prazosin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02226367/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Active duty soldiers participating in command mandated Army outpatient alcohol treatment were randomized to the brain-penetrant alpha-1 adrenergic receptor antagonist prazosin or placebo for 13 weeks.&#xD;
The period of enrollment and completion of study procedures was January, 2015, through July, 2018.&#xD;
The study was ended following enrollment of 158 participants due to end of funding.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Prazosin Hydrochloride</title>
          <description>Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.&#xD;
prazosin hydrochloride: study drug arm prazosin</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.&#xD;
placebo: study drug arm placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prazosin Hydrochloride</title>
          <description>Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.&#xD;
prazosin hydrochloride: study drug arm prazosin</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.&#xD;
placebo: study drug arm placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="102"/>
          </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="29.2" spread="6.5"/>
                    <measurement group_id="B2" value="29.8" spread="6.8"/>
                    <measurement group_id="B3" value="29.6" spread="6.6"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="97"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Penn Alcohol Craving Scale Score</title>
        <description>Penn Alcohol Craving Scale (PACS)&#xD;
The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.</description>
        <time_frame>Change at Week 13 from Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prazosin Hydrochloride</title>
            <description>Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.&#xD;
prazosin hydrochloride: study drug arm prazosin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.&#xD;
placebo: study drug arm placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Penn Alcohol Craving Scale Score</title>
          <description>Penn Alcohol Craving Scale (PACS)&#xD;
The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="4.1"/>
                    <measurement group_id="O2" value="8.8" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks.</time_frame>
      <desc>This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.</desc>
      <group_list>
        <group group_id="E1">
          <title>Prazosin Hydrochloride</title>
          <description>Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.&#xD;
prazosin hydrochloride: study drug arm prazosin</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.&#xD;
placebo: study drug arm placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>skull fracture and subdural hematoma</sub_title>
                <description>One participant randomized to placebo suffered a fractured skull and subdural hematoma resulting from a fall while alcohol intoxicated.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <description>One participant was psychiatrically hospitalized for suicidal ideation.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>anxiety associated with occupational stressors</sub_title>
                <description>One participant was hospitalized due to anxiety associated with occupational stressors.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </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="44" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness on standing</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Lightheadedness</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Peripheral edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed Mood</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Murray Raskind, MD</name_or_title>
      <organization>VA Puget Sound Health Care System</organization>
      <phone>(206) 277-3797</phone>
      <email>Murray.Raskind@va.gov</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/NCT02226367
org study id: W81XWH-12-2-0094
nct id: NCT02226367
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to evaluate if the drug prazosin:

        -  will decrease alcohol use in active duty members of the military who served in Iraq
           and/or Afghanistan and

        -  determine if presence or absence of posttraumatic stress disorder affects treatment.
The proposed study is a 19-week, titration to stable dose, randomized, two-group
      parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin
      for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in
      Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use
      disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or
      absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week
      Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than
      placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size
      will be greater in Service Members with PTSD than without PTSD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Penn Alcohol Craving Scale Score
time frame: Change at Week 13 from Baseline
description: Penn Alcohol Craving Scale (PACS)
The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.
arm group label: prazosin hydrochloride
arm group type: Active Comparator
description: Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.
intervention type: Drug
intervention name: prazosin hydrochloride
description: study drug arm prazosin
arm group label: prazosin hydrochloride
other name: prazosin
other name: Pfizer Minipress
intervention type: Drug
intervention name: placebo
description: study drug arm placebo
arm group label: placebo
other name: sugar pill
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Murray Raskind, MD
role: Principal Investigator
affiliation: Department of Veterans Affairs Puget Sound Health Care System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Stress Disorders, Traumatic
mesh term: Alcohol Drinking
mesh term: Combat Disorders
mesh term: Stress Disorders, Post-Traumatic
mesh term: Prazosin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 