<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/NCT03297944</url>
  </required_header>
  <id_info>
    <org_study_id>16-0260-F6A</org_study_id>
    <secondary_id>R36DA043714-01A1</secondary_id>
    <nct_id>NCT03297944</nct_id>
  </id_info>
  <brief_title>Sedative-Anxiolytic Effects on Simulated Driving Performance</brief_title>
  <official_title>Alprazolam and Simulated Driving Performance: Next Day Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marion Coe</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>University of Kentucky</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>
      This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car&#xD;
      the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed&#xD;
      or in the morning before using a driving simulator to assess impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">October 25, 2018</completion_date>
  <primary_completion_date type="Actual">October 25, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants and outcomes assessors were masked with respect to each individual intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Deviation of Lane Position (SLDP)</measure>
    <time_frame>16 hours</time_frame>
    <description>Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Psychomotor Impairment</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants received each intervention with alprazolam, zolpidem and placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprazolam 2mg (2ALP/PLC)</intervention_name>
    <description>2mg alprazolam administered at night, placebo administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprazolam 1mg (1ALP/PLC)</intervention_name>
    <description>1mg alprazolam administered at night, placebo administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprazolam 0.5mg (0.5ALP/PLC)</intervention_name>
    <description>0.5mg alprazolam administered at night, placebo administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zolpidem 10mg (ZOL/PLC)</intervention_name>
    <description>10mg alprazolam administered at night, placebo administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (PLC/PLC)</intervention_name>
    <description>Placebo administered at night, placebo administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprazolam 1mg (PLC/ALC)</intervention_name>
    <description>Placebo administered at night, 1mg alprazolam administered in the morning.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  valid driver's license&#xD;
&#xD;
          -  english-speaking and literate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using daily medication for chronic condition&#xD;
&#xD;
          -  acute narrow angle glaucoma&#xD;
&#xD;
          -  previous adverse experience with study drugs&#xD;
&#xD;
          -  experiences motion sickness in response to driving simulator&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  women who are pregnant, lactating, or planning on becoming pregnant&#xD;
&#xD;
          -  regular use of tobacco products&#xD;
&#xD;
          -  current substance use disorder&#xD;
&#xD;
          -  clinically significant ECG&#xD;
&#xD;
          -  current ongoing psychiatric disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marion Coe</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center on Drug and Alcohol Research</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>October 31, 2019</results_first_submitted>
  <results_first_submitted_qc>January 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2020</results_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Marion Coe</investigator_full_name>
    <investigator_title>Doctoral Candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zolpidem</mesh_term>
    <mesh_term>Alprazolam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03297944/ICF_000.pdf</document_url>
    </provided_document>
    <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>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03297944/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All 15 participants received every intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>All participants received all six interventions; combinations of placebo (PLC), alprazolam (ALP) or zolpidem (ZOL).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>2ALP/PLC</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1ALP/PLC</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>0.5ALP/PLC</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ZOL/PLC</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PLC/PLC</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PLC/ALP</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All 15 participants received each intervention.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.53" spread="8.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </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="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Standard Deviation of Lane Position (SLDP)</title>
        <description>Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.</description>
        <time_frame>16 hours</time_frame>
        <population>All 15 participants received each intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants received all 6 interventions.</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Deviation of Lane Position (SLDP)</title>
          <description>Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.</description>
          <population>All 15 participants received each intervention.</population>
          <units>distance (cm)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2ALP/PLC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.08" lower_limit="28.1" upper_limit="68.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1ALP/PLC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.28" lower_limit="28.0" upper_limit="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.5ALP/PLC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.06" lower_limit="27.6" upper_limit="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ZOL/PLC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.61" lower_limit="28.3" upper_limit="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLC/PLC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.30" lower_limit="29.7" upper_limit="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLC/ALP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.72" lower_limit="28.5" upper_limit="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>2ALP/PLC</title>
          <description>2mg Alprazolam administered at night, placebo administered in the morning&#xD;
Alprazolam: 0.5 to 2mg administered at night or in the morning</description>
        </group>
        <group group_id="E2">
          <title>1ALP/PLC</title>
          <description>1mg Alprazolam administered at night, placebo administered in the morning&#xD;
Alprazolam: 0.5 to 2mg administered at night or in the morning</description>
        </group>
        <group group_id="E3">
          <title>0.5ALP/PLC</title>
          <description>0.5mg Alprazolam administered at night, placebo administered in the morning&#xD;
Alprazolam: 0.5 to 2mg administered at night or in the morning</description>
        </group>
        <group group_id="E4">
          <title>ZOL/PLC</title>
          <description>10mg Zolpidem administered at night, placebo administered in the morning&#xD;
Zolpidem: 10mg administered at night or in the morning</description>
        </group>
        <group group_id="E5">
          <title>PLC/PLC</title>
          <description>Placebo administered at night, placebo administered in the morning&#xD;
Placebo: placebo administered at night and/or in the morning</description>
        </group>
        <group group_id="E6">
          <title>PLC/ALP</title>
          <description>Placebo administered at night, 1mg alprazolam administered in the morning&#xD;
Alprazolam: 0.5 to 2mg administered at night or in the morning</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach Ache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marion Coe</name_or_title>
      <organization>University of Kentucky</organization>
      <phone>859-257-6488</phone>
      <email>mcoe07@gmail.com</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/NCT03297944
org study id: 16-0260-F6A
secondary id: R36DA043714-01A1
nct id: NCT03297944
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car
      the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed
      or in the morning before using a driving simulator to assess impairment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
masking description: Participants and outcomes assessors were masked with respect to each individual intervention.
measure: Standard Deviation of Lane Position (SLDP)
time frame: 16 hours
description: Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
arm group label: All Participants
arm group type: Experimental
description: All participants received each intervention with alprazolam, zolpidem and placebo.
intervention type: Drug
intervention name: Alprazolam 2mg (2ALP/PLC)
description: 2mg alprazolam administered at night, placebo administered in the morning.
arm group label: All Participants
intervention type: Drug
intervention name: Alprazolam 1mg (1ALP/PLC)
description: 1mg alprazolam administered at night, placebo administered in the morning.
arm group label: All Participants
intervention type: Drug
intervention name: Alprazolam 0.5mg (0.5ALP/PLC)
description: 0.5mg alprazolam administered at night, placebo administered in the morning.
arm group label: All Participants
intervention type: Drug
intervention name: Zolpidem 10mg (ZOL/PLC)
description: 10mg alprazolam administered at night, placebo administered in the morning.
arm group label: All Participants
intervention type: Drug
intervention name: Placebo (PLC/PLC)
description: Placebo administered at night, placebo administered in the morning.
arm group label: All Participants
intervention type: Drug
intervention name: Alprazolam 1mg (PLC/ALC)
description: Placebo administered at night, 1mg alprazolam administered in the morning.
arm group label: All Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marion Coe
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Marion Coe
investigator title: Doctoral Candidate
mesh term: Psychomotor Disorders
mesh term: Zolpidem
mesh term: Alprazolam
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 