<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/NCT02187224</url>
  </required_header>
  <id_info>
    <org_study_id>1603017361</org_study_id>
    <secondary_id>24330</secondary_id>
    <nct_id>NCT02187224</nct_id>
  </id_info>
  <brief_title>Progesterone Effect on Individuals Diagnoses With AD and PTSD.</brief_title>
  <official_title>Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (PTSD).</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>Brain &amp; Behavior Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized control trial with an anticipated 36 participants diagnosed with&#xD;
      post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be&#xD;
      randomized to receive either progesterone (200 mg. bid) or placebo in identical looking&#xD;
      capsules for three days.&#xD;
&#xD;
      One goal of this research study is to test if progesterone is more effective than placebo in&#xD;
      reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm&#xD;
      among men and women with AD and PTSD. We hypothesize that progesterone in comparison to&#xD;
      placebo will significantly reduce craving for alcohol in response to trauma cues alone and in&#xD;
      combination with alcohol cues in individuals with AD and PTSD.&#xD;
&#xD;
      A second goal is to examine if there are gender differences in progesterone effects on stress&#xD;
      and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress&#xD;
      and craving will be stronger in women than in men. Participants will be recruited primarily&#xD;
      through advertisement, but also through the clinical facilities at the VA and from other&#xD;
      collaborators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 8, 2021</completion_date>
  <primary_completion_date type="Actual">September 8, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Visual Analogue Scale of Craving (VASC) Baseline no Script</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)</measure>
    <time_frame>25 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)</measure>
    <time_frame>65 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)</measure>
    <time_frame>80 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)</measure>
    <time_frame>95 minutes</time_frame>
    <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) Baseline no Script</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)</measure>
    <time_frame>25 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)</measure>
    <time_frame>65 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)</measure>
    <time_frame>80 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)</measure>
    <time_frame>95 minutes</time_frame>
    <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>State Trait Anxiety Inventory (STAI-6) Baseline no Script</measure>
    <time_frame>Baseline</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)</measure>
    <time_frame>25 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)</measure>
    <time_frame>65 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)</measure>
    <time_frame>80 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)</measure>
    <time_frame>95 minutes</time_frame>
    <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Alcohol Dependence</condition>
  <condition>Post-Traumatic Stress Disorder (PTSD)</condition>
  <arm_group>
    <arm_group_label>Progesterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone</intervention_name>
    <arm_group_label>Progesterone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Progesterone)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women ages 21 to 60;&#xD;
&#xD;
          2. Current diagnosis of AD and PTSD;&#xD;
&#xD;
          3. Drink regularly are not in an active phase of alcohol withdrawal;&#xD;
&#xD;
          4. Not at risk for suicide;&#xD;
&#xD;
          5. Not taking regularly psychoactive drugs including anxiolytics and antidepressants;&#xD;
&#xD;
          6. For women, have regular menses every 25-35 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current SCID diagnosis of any psychotic disorder;&#xD;
&#xD;
          2. Substance dependence (other than alcohol and nicotine) in the past 30 days;&#xD;
&#xD;
          3. Current unstable medical condition;&#xD;
&#xD;
          4. Positive test results at more than one baseline appointment on urine drug screens&#xD;
             conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for&#xD;
             women, amenorrhea, use of oral contraceptives;&#xD;
&#xD;
          5. Known allergy to progesterone or peanuts (vehicle for micronized progesterone);&#xD;
&#xD;
          6. History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or&#xD;
             Bleeding disorders, heart disease, diabetes or history of stroke.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Ralevski, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healtcase 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>April 2023</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>
  <results_first_submitted>September 13, 2022</results_first_submitted>
  <results_first_submitted_qc>April 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2023</results_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Dependence</keyword>
  <keyword>Post-Traumatic stress disorder (PTSD)</keyword>
  <keyword>Progesterone</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>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</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 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT02187224/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Progesterone All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Progesterone</description>
        </group>
        <group group_id="P2">
          <title>Placebo All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Placebo (for Progesterone)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Trauma Script First</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Neutral Script First</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not show up for test day</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Men and women ages 21 to 60; have current diagnosis of either AUD and comorbid PTSD</population>
      <group_list>
        <group group_id="B1">
          <title>Progesterone All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Progesterone</description>
        </group>
        <group group_id="B2">
          <title>Placebo All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Placebo (for Progesterone)</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="8"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="13"/>
          </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="48.4" spread="8.1"/>
                    <measurement group_id="B2" value="49.4" spread="11.4"/>
                    <measurement group_id="B3" value="48.9" spread="9.75"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) Baseline no Script</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>Baseline</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) Baseline no Script</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.78"/>
                    <measurement group_id="O2" value="0.60" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>State Trait Anxiety Inventory (STAI-6) Baseline no Script</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>Baseline</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>State Trait Anxiety Inventory (STAI-6) Baseline no Script</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.86" spread="0.911"/>
                    <measurement group_id="O2" value="9.60" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>10 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" spread="2.65"/>
                    <measurement group_id="O2" value="7.50" spread="1.32"/>
                    <measurement group_id="O3" value="6.50" spread="0.96"/>
                    <measurement group_id="O4" value="5.00" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>25 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" spread="2.75"/>
                    <measurement group_id="O2" value="16.25" spread="1.38"/>
                    <measurement group_id="O3" value="6.17" spread="0.60"/>
                    <measurement group_id="O4" value="5.00" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>40 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.00" spread="0.82"/>
                    <measurement group_id="O2" value="14.00" spread="0.41"/>
                    <measurement group_id="O3" value="7.07" spread="0.87"/>
                    <measurement group_id="O4" value="8.00" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>65 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" spread="0.67"/>
                    <measurement group_id="O2" value="5.00" spread="1.64"/>
                    <measurement group_id="O3" value="9.00" spread="3.16"/>
                    <measurement group_id="O4" value="9.00" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>80 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.17" spread="2.27"/>
                    <measurement group_id="O2" value="18.00" spread="5.57"/>
                    <measurement group_id="O3" value="6.00" spread="4.36"/>
                    <measurement group_id="O4" value="8.50" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)</title>
        <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
        <time_frame>95 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)</title>
          <description>Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as &quot;no or low anxiety&quot; (6-12), &quot;moderate anxiety&quot; (13-18), and &quot;high anxiety&quot; (19-24). (minimum score of 6 to a maximum score of 24)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.17" spread="1.96"/>
                    <measurement group_id="O2" value="14.00" spread="4.79"/>
                    <measurement group_id="O3" value="8.00" spread="3.95"/>
                    <measurement group_id="O4" value="8.25" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>10 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="1.73"/>
                    <measurement group_id="O2" value="0" spread="0.97"/>
                    <measurement group_id="O3" value="0.81" spread="0.80"/>
                    <measurement group_id="O4" value="0.32" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>25 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="1.80"/>
                    <measurement group_id="O2" value="3.93" spread="0.97"/>
                    <measurement group_id="O3" value="1.14" spread="0.80"/>
                    <measurement group_id="O4" value="0.33" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>40 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="1.75"/>
                    <measurement group_id="O2" value="1.92" spread="0.97"/>
                    <measurement group_id="O3" value="1.30" spread="0.79"/>
                    <measurement group_id="O4" value="0.40" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>65 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.81"/>
                    <measurement group_id="O2" value="0.20" spread="1.90"/>
                    <measurement group_id="O3" value="3.19" spread="1.60"/>
                    <measurement group_id="O4" value="0" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>80 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="0.80"/>
                    <measurement group_id="O2" value="2.27" spread="1.83"/>
                    <measurement group_id="O3" value="1.13" spread="1.81"/>
                    <measurement group_id="O4" value="0" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)</title>
        <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
        <time_frame>95 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)</title>
          <description>Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="0.80"/>
                    <measurement group_id="O2" value="4.31" spread="1.76"/>
                    <measurement group_id="O3" value="2.14" spread="1.79"/>
                    <measurement group_id="O4" value="0" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) Baseline no Script</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>Baseline</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) Baseline no Script</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.79"/>
                    <measurement group_id="O2" value="3.20" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>10 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1.68"/>
                    <measurement group_id="O2" value="1.26" spread="0.96"/>
                    <measurement group_id="O3" value="0.20" spread="0.80"/>
                    <measurement group_id="O4" value="0" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>25 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread="1.76"/>
                    <measurement group_id="O2" value="7.98" spread="0.97"/>
                    <measurement group_id="O3" value="0.03" spread="0.80"/>
                    <measurement group_id="O4" value="0" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>40 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1.91"/>
                    <measurement group_id="O2" value="4.39" spread="0.99"/>
                    <measurement group_id="O3" value="0.85" spread="0.81"/>
                    <measurement group_id="O4" value="0" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>65 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.81"/>
                    <measurement group_id="O2" value="0" spread="1.94"/>
                    <measurement group_id="O3" value="0" spread="1.90"/>
                    <measurement group_id="O4" value="2.15" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>80 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread="0.81"/>
                    <measurement group_id="O2" value="9.89" spread="1.99"/>
                    <measurement group_id="O3" value="0" spread="1.90"/>
                    <measurement group_id="O4" value="1.90" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)</title>
        <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
        <time_frame>95 minutes</time_frame>
        <population>All available data was utilized in the analysis using mixed models</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O2">
            <title>Placebo Trauma Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
          <group group_id="O3">
            <title>Progesterone Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive progesterone.&#xD;
Progesterone</description>
          </group>
          <group group_id="O4">
            <title>Placebo Neutral Script</title>
            <description>For the three days prior to each test day every participant in this arm will receive placebo.&#xD;
Placebo (for Progesterone)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)</title>
          <description>Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)</description>
          <population>All available data was utilized in the analysis using mixed models</population>
          <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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68" spread="0.81"/>
                    <measurement group_id="O2" value="9.76" spread="1.98"/>
                    <measurement group_id="O3" value="0" spread="1.98"/>
                    <measurement group_id="O4" value="2.05" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Progesterone All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Progesterone</description>
        </group>
        <group group_id="E2">
          <title>Placebo All Study Participants</title>
          <description>For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)&#xD;
Placebo (for Progesterone)</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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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>Elizabeth Ralevski</name_or_title>
      <organization>Yale University School of Medicine, Department of Psychiatry</organization>
      <phone>203-932-5711 ext 4282</phone>
      <email>elizabeth.ralevski@yale.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/NCT02187224
org study id: 1603017361
secondary id: 24330
nct id: NCT02187224
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a randomized control trial with an anticipated 36 participants diagnosed with
      post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be
      randomized to receive either progesterone (200 mg. bid) or placebo in identical looking
      capsules for three days.

      One goal of this research study is to test if progesterone is more effective than placebo in
      reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm
      among men and women with AD and PTSD. We hypothesize that progesterone in comparison to
      placebo will significantly reduce craving for alcohol in response to trauma cues alone and in
      combination with alcohol cues in individuals with AD and PTSD.

      A second goal is to examine if there are gender differences in progesterone effects on stress
      and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress
      and craving will be stronger in women than in men. Participants will be recruited primarily
      through advertisement, but also through the clinical facilities at the VA and from other
      collaborators.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual Analogue Scale of Craving (VASC) Baseline no Script
time frame: Baseline
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)
time frame: 10 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)
time frame: 25 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)
time frame: 40 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)
time frame: 65 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)
time frame: 80 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)
time frame: 95 minutes
description: Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
measure: Visual Analogue Scale of Anxiety (VASA) Baseline no Script
time frame: Baseline
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)
time frame: 10 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)
time frame: 25 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)
time frame: 40 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)
time frame: 65 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)
time frame: 80 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)
time frame: 95 minutes
description: Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
measure: State Trait Anxiety Inventory (STAI-6) Baseline no Script
time frame: Baseline
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)
time frame: 10 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)
time frame: 25 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)
time frame: 40 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)
time frame: 65 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)
time frame: 80 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
measure: Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)
time frame: 95 minutes
description: Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
arm group label: Progesterone
arm group type: Experimental
description: For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)
arm group label: Placebo
arm group type: Placebo Comparator
description: For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)
intervention type: Drug
intervention name: Progesterone
arm group label: Progesterone
intervention type: Drug
intervention name: Placebo (for Progesterone)
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Elizabeth Ralevski, Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Progesterone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 