<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/NCT03251326</url>
  </required_header>
  <id_info>
    <org_study_id>6971</org_study_id>
    <secondary_id>U54DA037842</secondary_id>
    <nct_id>NCT03251326</nct_id>
  </id_info>
  <brief_title>Nabilone in Cannabis Users With PTSD</brief_title>
  <official_title>Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the prevalence of cannabis use among the PTSD population and self-reports that it is&#xD;
      used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are&#xD;
      unknown. The purpose of this placebo-controlled, within-subject study is to assess the&#xD;
      effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the&#xD;
      primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in&#xD;
      cannabis smokers with PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will compare the effects of smoked cannabis and nabilone on attentional bias&#xD;
      toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and&#xD;
      non-trauma-related images and physiological reactivity to these stimuli in individuals with&#xD;
      CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone&#xD;
      compared to smoked cannabis in this population, a critical aspect in determining the&#xD;
      potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of&#xD;
      nabilone will be compared to propranolol as a positive control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cue Reactivity (Emotional Stroop Task)</measure>
    <time_frame>1 month</time_frame>
    <description>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Cannabis</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Nabilone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nabilone capsules (4 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propranolol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propranolol capsules (40mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoked cannabis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(0.0 and 5.6% THC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nabilone</intervention_name>
    <description>Nabilone capsules (4 mg)</description>
    <arm_group_label>Nabilone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabis</intervention_name>
    <description>Cigarettes (0.0 and 5.6% THC)</description>
    <arm_group_label>Smoked cannabis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol</intervention_name>
    <description>Propranolol capsules (40mg)</description>
    <arm_group_label>Propranolol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current cannabis use&#xD;
&#xD;
          -  PTSD symptoms&#xD;
&#xD;
          -  Able to give informed consent and comply with study procedures&#xD;
&#xD;
          -  Women who are normally cycling and practicing an effective form of birth control other&#xD;
             than hormonal contraceptives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meeting criteria for certain current psychiatric disorders&#xD;
&#xD;
          -  Clinical laboratory tests outside of normal limits&#xD;
&#xD;
          -  History of clinically significant cardiac or respiratory diagnoses&#xD;
&#xD;
          -  Current parole or probation&#xD;
&#xD;
          -  Women who are currently pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>August 18, 2020</results_first_submitted>
  <results_first_submitted_qc>September 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2020</results_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Margaret Haney</investigator_full_name>
    <investigator_title>Professor of Neurobiology (in Psychiatry) at CUMC</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</mesh_term>
    <mesh_term>Nabilone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03251326/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was terminated and the PI and the study team left the institution; as such, no outcome data is available.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Nab &gt; Plac Prop &gt; Plac Cann</title>
          <description>Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</description>
        </group>
        <group group_id="P2">
          <title>Plac Nab &gt; Act Prop &gt; Plac Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)</description>
        </group>
        <group group_id="P3">
          <title>Plac Nab &gt; Plac Prop &gt; Act Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)</description>
        </group>
        <group group_id="P4">
          <title>Plac Nab &gt; Plac Prop &gt; Plac Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nabilone/Propranolol/Placebo + Smoked Cannabis/Placebo Placebo</title>
          <description>Nabilone capsules (4 mg) Propranolol (40mg) Placebo (0mg nabilone or propranolol) Placebo cannabis (0.0% THC) Smoked cannabis (5.6% THC)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cue Reactivity (Emotional Stroop Task)</title>
        <description>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</description>
        <time_frame>1 month</time_frame>
        <population>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Nab &gt; Plac Prop &gt; Plac Cann</title>
            <description>Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</description>
          </group>
          <group group_id="O2">
            <title>Plac Nab &gt; Act Prop &gt; Plac Cann</title>
            <description>Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)</description>
          </group>
          <group group_id="O3">
            <title>Plac Nab &gt; Plac Prop &gt; Act Cann</title>
            <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)</description>
          </group>
          <group group_id="O4">
            <title>Plac Nab &gt; Plac Prop &gt; Plac Cann</title>
            <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</description>
          </group>
        </group_list>
        <measure>
          <title>Cue Reactivity (Emotional Stroop Task)</title>
          <description>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</description>
          <population>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected throughout the duration of the study (October 2015 - June 2019). Each participant's was enrolled in the study for approximately 1.5 months, during which adverse event data was collected (baseline through each of 4 experimental sessions).</time_frame>
      <desc>We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active Nab &gt; Plac Prop &gt; Plac Cann</title>
          <description>Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</description>
        </group>
        <group group_id="E2">
          <title>Plac Nab &gt; Act Prop &gt; Plac Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)</description>
        </group>
        <group group_id="E3">
          <title>Plac Nab &gt; Plac Prop &gt; Act Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)</description>
        </group>
        <group group_id="E4">
          <title>Plac Nab &gt; Plac Prop &gt; Plac Cann</title>
          <description>Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Margaret Haney, Ph.D.</name_or_title>
      <organization>New York State Psychiatric Institute</organization>
      <phone>646-774-6129</phone>
      <email>meg.haney@nyspi.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251326
org study id: 6971
secondary id: U54DA037842
nct id: NCT03251326
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Despite the prevalence of cannabis use among the PTSD population and self-reports that it is
      used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are
      unknown. The purpose of this placebo-controlled, within-subject study is to assess the
      effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the
      primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in
      cannabis smokers with PTSD.
This study will compare the effects of smoked cannabis and nabilone on attentional bias
      toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and
      non-trauma-related images and physiological reactivity to these stimuli in individuals with
      CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone
      compared to smoked cannabis in this population, a critical aspect in determining the
      potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of
      nabilone will be compared to propranolol as a positive control.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Cue Reactivity (Emotional Stroop Task)
time frame: 1 month
description: We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.
arm group label: Nabilone
arm group type: Experimental
description: Nabilone capsules (4 mg)
arm group label: Propranolol
arm group type: Active Comparator
description: Propranolol capsules (40mg)
arm group label: Smoked cannabis
arm group type: Experimental
description: (0.0 and 5.6% THC)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules
intervention type: Drug
intervention name: Nabilone
description: Nabilone capsules (4 mg)
arm group label: Nabilone
intervention type: Drug
intervention name: Cannabis
description: Cigarettes (0.0 and 5.6% THC)
arm group label: Smoked cannabis
intervention type: Drug
intervention name: Propranolol
description: Propranolol capsules (40mg)
arm group label: Propranolol
intervention type: Drug
intervention name: Placebo
description: Placebo capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Margaret Haney
investigator title: Professor of Neurobiology (in Psychiatry) at CUMC
mesh term: Marijuana Abuse
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Propranolol
mesh term: Nabilone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 