<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/NCT03008005</url>
  </required_header>
  <id_info>
    <org_study_id>1R61MH111935-01</org_study_id>
    <nct_id>NCT03008005</nct_id>
  </id_info>
  <brief_title>Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study</brief_title>
  <official_title>Effects of THC on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to look at how a type of drug called cannabinoids are related to&#xD;
      the processing of fear signals, the experience of emotions and fear, and the pattern of&#xD;
      activity in the brain that is involved in these processes and how this relates to the&#xD;
      development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs&#xD;
      after experiencing a traumatic event(s) and is characterized by unwanted memories of the&#xD;
      trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of&#xD;
      the event, difficulty experiencing emotions, loss of interest in activities the person used&#xD;
      to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger&#xD;
      and hypervigilance. The information gained from this study could lead to the development of&#xD;
      new treatments for persons who suffer from anxiety or fear-based disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total time that for each participant involved in this study is 5 visits, as outlined&#xD;
      below:&#xD;
&#xD;
      Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential&#xD;
      participant will learn about the study procedures, sign the informed consent documents, and&#xD;
      fill out a packet of forms that ask about his or her race and ethnic background, use of drugs&#xD;
      and alcohol and physical and mental health.&#xD;
&#xD;
      Visit 2: Behavioral Tests: During this visit the participant will complete several computer&#xD;
      tasks, and the study staff will be measuring reaction time and psychophysiological&#xD;
      measures.The tasks that the participant will perform will show three different images and an&#xD;
      aversive stimulus (e.g. loud burst of noise or animated snake) may follow one image most of&#xD;
      the time, while the other images may never be followed by the aversive cue. The participant&#xD;
      will need to try to predict whether the aversive cue will occur or not based on which image&#xD;
      is shown and will be asked to repeatedly rate on a scale how likely it is that he or she&#xD;
      thinks an aversive cue will occur after each image. Lastly, during the session the&#xD;
      participant will also be asked to report his or her level of anxiety on a scale from 0 to&#xD;
      100.&#xD;
&#xD;
      Visit 3: Behavioral Tests with Drug or Placebo and Magnetic Resonance (MR) scan: For safety&#xD;
      reasons participant will not be allowed to take any drugs for at least 24 hours before this&#xD;
      visit, and should not use marijuana for at least 2 weeks before. Participants will be&#xD;
      required to pass a urine drug test (and pregnancy test for women) and breathalyzer test&#xD;
      before being allowed to continue with this visit. The participant will also not be allowed to&#xD;
      drive himself or herself home from this visit, so he or she should arrange a friend or family&#xD;
      member to pick him or her up or a taxi can be called by our research staff.&#xD;
&#xD;
      The participant will view the same images he or she did on the previous day (Visit 2), and&#xD;
      may experience the same aversive stimulus as during Visit 2. The participant will again be&#xD;
      asked to rate how much he or she expects to experience the aversive stimulus after each image&#xD;
      and he or she will also be asked to report his or her level of anxiety on a scale from 0 to&#xD;
      100. However, about 2 hours before the task begins, the participant will be asked to swallow&#xD;
      a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill).&#xD;
      Dronabinol is a Food &amp; Drug Administration (FDA) approved drug and the doses (5mg or 10mg;&#xD;
      one time) are unlikely to have any effects that last beyond the duration of the study visit.&#xD;
      About every 30 minutes after taking the pill, the participant will fill out some&#xD;
      questionnaires about mood and how he or she is feeling at the moment.&#xD;
&#xD;
      Visit 4: Behavioral Tests and MR scan: This visit will be very similar to Visit 2.&#xD;
      Participants will participate in the same type of task inside the MR scanner, while the study&#xD;
      staff measures reaction time and psychophysiological responding and brain activation.&#xD;
      Participants will view the same images he or she did previously, and may experience the same&#xD;
      aversive stimulus as during Visit 2. Participants will again be asked to rate how much they&#xD;
      expect to experience the aversive stimulus after each image and will also be asked to report&#xD;
      their level of anxiety on a scale from 0 to 100.&#xD;
&#xD;
      Visit 5: Behavioral Tests and MR scan: This visit will occur approximately 1 week after Visit&#xD;
      4 and will have the same procedure. Participants will participate in the same type of task&#xD;
      inside the MR scanner, while the study staff measures reaction time and psychophysiological&#xD;
      responding and brain activation. Participants will again be asked to rate how much they&#xD;
      expect to experience the aversive stimulus after each image and will also be asked to report&#xD;
      their level of anxiety on a scale from 0 to 100.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain Measures</measure>
    <time_frame>Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day</time_frame>
    <description>Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expectancy Ratings</measure>
    <time_frame>Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.</time_frame>
    <description>To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of &quot;yes&quot;, &quot;no&quot;, and &quot;I don't know&quot; are collected on the first (early) trial of the CS and the last (late) trial of the CS.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>PostTraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dronabinol Cap 5 milligrams (MG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dronabinol Cap 10 milligrams (MG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.</description>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <other_name>sugar pill</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dronabinol Cap 5 milligrams (MG)</intervention_name>
    <description>Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
    <arm_group_label>Dronabinol Cap 5 milligrams (MG)</arm_group_label>
    <other_name>Marinol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dronabinol Cap 10 milligrams (MG)</intervention_name>
    <description>Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
    <arm_group_label>Dronabinol Cap 10 milligrams (MG)</arm_group_label>
    <other_name>Marinol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Age between 18-50 years old,&#xD;
&#xD;
          -  Physically and neurologically healthy [confirmed by a comprehensive medical history]&#xD;
&#xD;
          -  Current PTSD diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinically significant medical or neurologic condition or neurocognitive dysfunction&#xD;
             that would affect function and/or task performance and/or interfere with the study&#xD;
             protocol&#xD;
&#xD;
          -  any current (or within past 2 months) medical condition requiring medication that&#xD;
             would interact with dronabinol or interfere with the study protocol&#xD;
&#xD;
          -  risk of harm to self or others that requires immediate intervention&#xD;
&#xD;
          -  presence of contraindications, current or past allergic or adverse reaction, or known&#xD;
             sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC,&#xD;
             cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)&#xD;
&#xD;
          -  lack of fluency in English&#xD;
&#xD;
          -  positive drug screen or alcohol breathalyzer&#xD;
&#xD;
          -  unwilling/unable to sign informed consent document&#xD;
&#xD;
          -  currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women)&#xD;
&#xD;
          -  under 18 or over 50 years of age&#xD;
&#xD;
          -  traumatic brain injury (as defined by The American Congress of Rehabilitation as a&#xD;
             person who has had a traumatically induced physiological disruption of brain function&#xD;
             (i.e., the head being struck, the head striking an object, and/or the brain undergoing&#xD;
             an acceleration/deceleration movement (i.e., whiplash) without direct external trauma&#xD;
             to the head), as manifested by at least one of the following: any loss of&#xD;
             consciousness; any loss of memory for events immediately before or after the injury;&#xD;
             any alteration in mental status at the time of the incident; or focal neurological&#xD;
             deficits that may or may not be transient)&#xD;
&#xD;
          -  inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as&#xD;
             determined by self-report and/or a preliminary session in a mock scanner&#xD;
&#xD;
          -  left-handed;&#xD;
&#xD;
          -  presence of ferrous-containing metals within the body (e.g., aneurysm clips,&#xD;
             shrapnel/retained particles)&#xD;
&#xD;
          -  anticipation of a required drug test in the 4 weeks following the study.&#xD;
&#xD;
          -  current diagnosis of a mood, anxiety, or other disorder that is more clinically&#xD;
             salient than PTSD&#xD;
&#xD;
          -  current moderate or severe alcohol/drug use disorder or in the past 8 weeks&#xD;
&#xD;
          -  current or past diagnosis of bipolar and other related disorders, schizophrenia&#xD;
             spectrum, or other psychotic disorders&#xD;
&#xD;
          -  concomitant treatments with medication known to have drug interactions with&#xD;
             dronabinol, such as, central nervous system depressants (barbiturates,&#xD;
             benzodiazepines, buspirone, lithium, etc) and anticholinergic agents (atropine,&#xD;
             scopolamine, antihistamines, etc).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine A. Rabinak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eugene Applebaum College of Pharmacy and Health Sciences</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>May 24, 2022</results_first_submitted>
  <results_first_submitted_qc>August 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2022</results_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Christine Rabinak, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Dronabinol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03008005/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03008005/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Oral Capsule</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of placebo.</description>
        </group>
        <group group_id="P2">
          <title>Dronabinol Cap 5 Milligrams (MG)</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of 5mg dronabinol.</description>
        </group>
        <group group_id="P3">
          <title>Dronabinol Cap 10 Milligrams (MG)</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of 10mg dronabinol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Oral Capsule</title>
          <description>Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo.</description>
        </group>
        <group group_id="B2">
          <title>Dronabinol Cap 5 Milligrams (MG)</title>
          <description>Trauma-exposed individuals with PTSD that received a one-time oral dose of 5mg dronabinol.</description>
        </group>
        <group group_id="B3">
          <title>Dronabinol Cap 10 Milligrams (MG)</title>
          <description>Trauma-exposed individuals with PTSD that received a one-time oral dose of 10mg dronabinol.</description>
        </group>
        <group group_id="B4">
          <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="14"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="26.29" spread="10.22"/>
                    <measurement group_id="B2" value="25.59" spread="9.81"/>
                    <measurement group_id="B3" value="25.13" spread="6.63"/>
                    <measurement group_id="B4" value="25.65" spread="8.85"/>
                  </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="45"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CAPS-5</title>
          <description>Clinician Administered PTSD Scale for DSM 5 Total severity score: Sum of values on the instrument that falls on a scale 0-80. Higher numbers represent more severe PTSD symptoms</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.71" spread="12.29"/>
                    <measurement group_id="B2" value="35.65" spread="10.25"/>
                    <measurement group_id="B3" value="35.60" spread="12.27"/>
                    <measurement group_id="B4" value="35.65" spread="11.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PCL-5</title>
          <description>PTSD Checklist for DSM 5 Total Score: Sum of values on the instrument that falls on a scale 0-80. Higher numbers represent more severe PTSD symptoms</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.29" spread="17.17"/>
                    <measurement group_id="B2" value="45.71" spread="15.56"/>
                    <measurement group_id="B3" value="46.40" spread="16.65"/>
                    <measurement group_id="B4" value="43.98" spread="16.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Brain Measures</title>
        <description>Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.</description>
        <time_frame>Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Oral Capsule</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Placebo Oral Capsule: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.</description>
          </group>
          <group group_id="O2">
            <title>Dronabinol Cap 5 Milligrams (MG)</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Dronabinol Cap 5 milligrams (MG): Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
          </group>
          <group group_id="O3">
            <title>Dronabinol Cap 10 Milligrams (MG)</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Dronabinol Cap 10 milligrams (MG): Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Measures</title>
          <description>Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.</description>
          <units>arbitrary units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extinction Learning CS+E Amygdala-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.039567327" spread="0.241268856"/>
                    <measurement group_id="O2" value="0.092173636" spread="0.327156274"/>
                    <measurement group_id="O3" value="0.149446357" spread="0.335179325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction Learning CS+E Hippocampus-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.021618" spread="0.186131283"/>
                    <measurement group_id="O2" value="0.000147182" spread="0.135589364"/>
                    <measurement group_id="O3" value="0.0734664" spread="0.112658087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction Learning CS+E vmPFC-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.100398455" spread="0.251500983"/>
                    <measurement group_id="O2" value="-0.140956909" spread="0.199637856"/>
                    <measurement group_id="O3" value="-0.014101643" spread="0.20111521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction Learning CS- Amygdala-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.058886909" spread="0.204782961"/>
                    <measurement group_id="O2" value="-0.006294273" spread="0.261622699"/>
                    <measurement group_id="O3" value="0.160143" spread="0.241651249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction Learning CS- Hippocampus-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.059069435" spread="0.127779008"/>
                    <measurement group_id="O2" value="-0.133546182" spread="0.107201148"/>
                    <measurement group_id="O3" value="-0.022569714" spread="0.101622507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction Learning CS- vmPFC-Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.108475118" spread="0.164705482"/>
                    <measurement group_id="O2" value="-0.144499545" spread="0.207477253"/>
                    <measurement group_id="O3" value="-0.058264393" spread="0.166826016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.064068818" spread="0.126060842"/>
                    <measurement group_id="O2" value="0.05063" spread="0.246216857"/>
                    <measurement group_id="O3" value="0.021313529" spread="0.144489742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.018730882" spread="0.105994504"/>
                    <measurement group_id="O2" value="-0.009476018" spread="0.079625507"/>
                    <measurement group_id="O3" value="-0.008622411" spread="0.061309342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.092562327" spread="0.12096037"/>
                    <measurement group_id="O2" value="-0.046500136" spread="0.148710336"/>
                    <measurement group_id="O3" value="-0.042297714" spread="0.131211376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.023179891" spread="0.369129301"/>
                    <measurement group_id="O2" value="-0.045574364" spread="0.217199197"/>
                    <measurement group_id="O3" value="0.084785971" spread="0.188667772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.016318864" spread="0.130857648"/>
                    <measurement group_id="O2" value="-0.012782118" spread="0.074290578"/>
                    <measurement group_id="O3" value="0.021303429" spread="0.086215257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.025044173" spread="0.087226891"/>
                    <measurement group_id="O2" value="-0.111483273" spread="0.136683884"/>
                    <measurement group_id="O3" value="-0.023582643" spread="0.092589989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.073318518" spread="0.176984276"/>
                    <measurement group_id="O2" value="-0.002491309" spread="0.192822633"/>
                    <measurement group_id="O3" value="0.106574214" spread="0.294631794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0027553" spread="0.114973037"/>
                    <measurement group_id="O2" value="-0.048798436" spread="0.104668268"/>
                    <measurement group_id="O3" value="0.039578357" spread="0.157749137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.063881291" spread="0.195166763"/>
                    <measurement group_id="O2" value="-0.11082" spread="0.125147494"/>
                    <measurement group_id="O3" value="-0.068200429" spread="0.173367568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007166727" spread="0.16281838"/>
                    <measurement group_id="O2" value="0.085493291" spread="0.195124774"/>
                    <measurement group_id="O3" value="-0.038971376" spread="0.225437092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.042572273" spread="0.121258736"/>
                    <measurement group_id="O2" value="0.053855418" spread="0.10101509"/>
                    <measurement group_id="O3" value="0.022821236" spread="0.09697586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.025462455" spread="0.061109422"/>
                    <measurement group_id="O2" value="-0.051927636" spread="0.137163274"/>
                    <measurement group_id="O3" value="-0.044782714" spread="0.149704378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.038667909" spread="0.313060636"/>
                    <measurement group_id="O2" value="0.041082273" spread="0.249335278"/>
                    <measurement group_id="O3" value="0.089871571" spread="0.284506548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.010737545" spread="0.135826418"/>
                    <measurement group_id="O2" value="0.028653909" spread="0.108329415"/>
                    <measurement group_id="O3" value="0.026597157" spread="0.177134712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0115975" spread="0.174869566"/>
                    <measurement group_id="O2" value="-0.035996455" spread="0.159479443"/>
                    <measurement group_id="O3" value="0.015976671" spread="0.173108329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Amygdala-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.033922182" spread="0.196452024"/>
                    <measurement group_id="O2" value="-0.019035273" spread="0.347223043"/>
                    <measurement group_id="O3" value="0.04350675" spread="0.228228503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Hippocampus-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001226509" spread="0.14949891"/>
                    <measurement group_id="O2" value="0.040038355" spread="0.128456906"/>
                    <measurement group_id="O3" value="0.037054743" spread="0.086797744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U vmPFC-Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.024311655" spread="0.109098602"/>
                    <measurement group_id="O2" value="-0.063822713" spread="0.149376423"/>
                    <measurement group_id="O3" value="-0.028642293" spread="0.086767322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.102081909" spread="0.267334482"/>
                    <measurement group_id="O2" value="-0.112056636" spread="0.329023209"/>
                    <measurement group_id="O3" value="0.175857929" spread="0.2753103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.066236364" spread="0.194500373"/>
                    <measurement group_id="O2" value="-0.017467364" spread="0.172543206"/>
                    <measurement group_id="O3" value="0.127993357" spread="0.130790704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0327043" spread="0.157330444"/>
                    <measurement group_id="O2" value="-0.017208209" spread="0.168514694"/>
                    <measurement group_id="O3" value="0.007210571" spread="0.152128778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.095167636" spread="0.307824688"/>
                    <measurement group_id="O2" value="-0.060291409" spread="0.232370391"/>
                    <measurement group_id="O3" value="0.154838214" spread="0.250376068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.007481636" spread="0.231953032"/>
                    <measurement group_id="O2" value="0.006147773" spread="0.11636263"/>
                    <measurement group_id="O3" value="0.0426459" spread="0.145582746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.017899909" spread="0.164153846"/>
                    <measurement group_id="O2" value="-0.027662455" spread="0.149608896"/>
                    <measurement group_id="O3" value="-0.056348421" spread="0.211452199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.067971218" spread="0.201754089"/>
                    <measurement group_id="O2" value="0.052176091" spread="0.407452643"/>
                    <measurement group_id="O3" value="0.089821286" spread="0.468006999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.023053471" spread="0.152490758"/>
                    <measurement group_id="O2" value="-0.009212182" spread="0.139630295"/>
                    <measurement group_id="O3" value="0.073768357" spread="0.26781902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.041723673" spread="0.105402346"/>
                    <measurement group_id="O2" value="-0.024672805" spread="0.125923794"/>
                    <measurement group_id="O3" value="-0.026101643" spread="0.16205021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.061899727" spread="0.372039765"/>
                    <measurement group_id="O2" value="0.076936818" spread="0.234232725"/>
                    <measurement group_id="O3" value="0.091302143" spread="0.274868067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.063149555" spread="0.194680145"/>
                    <measurement group_id="O2" value="0.031223436" spread="0.165435695"/>
                    <measurement group_id="O3" value="0.031342243" spread="0.179872674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.066609182" spread="0.266328372"/>
                    <measurement group_id="O2" value="0.040283" spread="0.147068638"/>
                    <measurement group_id="O3" value="0.048598129" spread="0.198056416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.183916727" spread="0.306917185"/>
                    <measurement group_id="O2" value="0.124069727" spread="0.211486836"/>
                    <measurement group_id="O3" value="0.15168205" spread="0.351211445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.013174" spread="0.209268027"/>
                    <measurement group_id="O2" value="0.056026436" spread="0.151187117"/>
                    <measurement group_id="O3" value="0.041636779" spread="0.19943295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.018359999" spread="0.217672587"/>
                    <measurement group_id="O2" value="0.0344149" spread="0.167694371"/>
                    <measurement group_id="O3" value="-0.048354143" spread="0.323141034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Amygdala-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.312260455" spread="0.25005898"/>
                    <measurement group_id="O2" value="0.182693845" spread="0.255384016"/>
                    <measurement group_id="O3" value="0.095871914" spread="0.542394387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Hippocampus-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.111670727" spread="0.190179528"/>
                    <measurement group_id="O2" value="0.057369273" spread="0.133003425"/>
                    <measurement group_id="O3" value="0.009984107" spread="0.265241884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U vmPFC-Visit 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.056020818" spread="0.195016729"/>
                    <measurement group_id="O2" value="0.085382818" spread="0.121708322"/>
                    <measurement group_id="O3" value="0.016284214" spread="0.334969996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Expectancy Ratings</title>
        <description>To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of &quot;yes&quot;, &quot;no&quot;, and &quot;I don't know&quot; are collected on the first (early) trial of the CS and the last (late) trial of the CS.</description>
        <time_frame>Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.</time_frame>
        <population>The number analyzed per row may differ from the overall analyzed due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Oral Capsule</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Placebo Oral Capsule: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.</description>
          </group>
          <group group_id="O2">
            <title>Dronabinol Cap 5 Milligrams (MG)</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Dronabinol Cap 5 milligrams (MG): Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
          </group>
          <group group_id="O3">
            <title>Dronabinol Cap 10 Milligrams (MG)</title>
            <description>In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.&#xD;
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).&#xD;
Dronabinol Cap 10 milligrams (MG): Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.</description>
          </group>
        </group_list>
        <measure>
          <title>Expectancy Ratings</title>
          <description>To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of &quot;yes&quot;, &quot;no&quot;, and &quot;I don't know&quot; are collected on the first (early) trial of the CS and the last (late) trial of the CS.</description>
          <population>The number analyzed per row may differ from the overall analyzed due to missing data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acquisition CS+E Early-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acquisition CS+U Early-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acquisition CS- Early-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acquisition CS+E Late-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acquisition CS+U Late-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acquisition CS- Late-Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction CS+E Early-Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction CS- Early-Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction CS+E Late-Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extinction CS- Late-Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Early-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Late-Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+E Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS+U Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recall CS- Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Early-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+E Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS+U Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renewal CS- Late-Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>I Don't Know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events are collected when a participant in enrolled in the study until study completion, which is approximately over a 3 week duration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Oral Capsule</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of placebo.</description>
        </group>
        <group group_id="E2">
          <title>Dronabinol Cap 5 Milligrams (MG)</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of 5mg dronabinol.</description>
        </group>
        <group group_id="E3">
          <title>Dronabinol Cap 10 Milligrams (MG)</title>
          <description>Trauma-exposed individuals that received a one-time oral dose of 10mg dronabinol.</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Christine Rabinak, Principal Investigator</name_or_title>
      <organization>Wayne State University</organization>
      <phone>(313) 577-9875</phone>
      <email>rabinak@wayne.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/NCT03008005
org study id: 1R61MH111935-01
nct id: NCT03008005
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this study is to look at how a type of drug called cannabinoids are related to
      the processing of fear signals, the experience of emotions and fear, and the pattern of
      activity in the brain that is involved in these processes and how this relates to the
      development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs
      after experiencing a traumatic event(s) and is characterized by unwanted memories of the
      trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of
      the event, difficulty experiencing emotions, loss of interest in activities the person used
      to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger
      and hypervigilance. The information gained from this study could lead to the development of
      new treatments for persons who suffer from anxiety or fear-based disorders.
The total time that for each participant involved in this study is 5 visits, as outlined
      below:

      Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential
      participant will learn about the study procedures, sign the informed consent documents, and
      fill out a packet of forms that ask about his or her race and ethnic background, use of drugs
      and alcohol and physical and mental health.

      Visit 2: Behavioral Tests: During this visit the participant will complete several computer
      tasks, and the study staff will be measuring reaction time and psychophysiological
      measures.The tasks that the participant will perform will show three different images and an
      aversive stimulus (e.g. loud burst of noise or animated snake) may follow one image most of
      the time, while the other images may never be followed by the aversive cue. The participant
      will need to try to predict whether the aversive cue will occur or not based on which image
      is shown and will be asked to repeatedly rate on a scale how likely it is that he or she
      thinks an aversive cue will occur after each image. Lastly, during the session the
      participant will also be asked to report his or her level of anxiety on a scale from 0 to
      100.

      Visit 3: Behavioral Tests with Drug or Placebo and Magnetic Resonance (MR) scan: For safety
      reasons participant will not be allowed to take any drugs for at least 24 hours before this
      visit, and should not use marijuana for at least 2 weeks before. Participants will be
      required to pass a urine drug test (and pregnancy test for women) and breathalyzer test
      before being allowed to continue with this visit. The participant will also not be allowed to
      drive himself or herself home from this visit, so he or she should arrange a friend or family
      member to pick him or her up or a taxi can be called by our research staff.

      The participant will view the same images he or she did on the previous day (Visit 2), and
      may experience the same aversive stimulus as during Visit 2. The participant will again be
      asked to rate how much he or she expects to experience the aversive stimulus after each image
      and he or she will also be asked to report his or her level of anxiety on a scale from 0 to
      100. However, about 2 hours before the task begins, the participant will be asked to swallow
      a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill).
      Dronabinol is a Food & Drug Administration (FDA) approved drug and the doses (5mg or 10mg;
      one time) are unlikely to have any effects that last beyond the duration of the study visit.
      About every 30 minutes after taking the pill, the participant will fill out some
      questionnaires about mood and how he or she is feeling at the moment.

      Visit 4: Behavioral Tests and MR scan: This visit will be very similar to Visit 2.
      Participants will participate in the same type of task inside the MR scanner, while the study
      staff measures reaction time and psychophysiological responding and brain activation.
      Participants will view the same images he or she did previously, and may experience the same
      aversive stimulus as during Visit 2. Participants will again be asked to rate how much they
      expect to experience the aversive stimulus after each image and will also be asked to report
      their level of anxiety on a scale from 0 to 100.

      Visit 5: Behavioral Tests and MR scan: This visit will occur approximately 1 week after Visit
      4 and will have the same procedure. Participants will participate in the same type of task
      inside the MR scanner, while the study staff measures reaction time and psychophysiological
      responding and brain activation. Participants will again be asked to rate how much they
      expect to experience the aversive stimulus after each image and will also be asked to report
      their level of anxiety on a scale from 0 to 100.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Brain Measures
time frame: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day
description: Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.
measure: Expectancy Ratings
time frame: Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.
description: To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of "yes", "no", and "I don't know" are collected on the first (early) trial of the CS and the last (late) trial of the CS.
arm group label: Placebo Oral Capsule
arm group type: Placebo Comparator
description: In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
arm group label: Dronabinol Cap 5 milligrams (MG)
arm group type: Experimental
description: In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
arm group label: Dronabinol Cap 10 milligrams (MG)
arm group type: Experimental
description: In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.
arm group label: Placebo Oral Capsule
other name: sugar pill
intervention type: Drug
intervention name: Dronabinol Cap 5 milligrams (MG)
description: Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
arm group label: Dronabinol Cap 5 milligrams (MG)
other name: Marinol
intervention type: Drug
intervention name: Dronabinol Cap 10 milligrams (MG)
description: Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
arm group label: Dronabinol Cap 10 milligrams (MG)
other name: Marinol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Christine A. Rabinak, PhD
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Christine Rabinak, PhD
investigator title: Assistant Professor
mesh term: Stress Disorders, Post-Traumatic
mesh term: Dronabinol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 