<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/NCT04429685</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2019-1792</org_study_id>
    <nct_id>NCT04429685</nct_id>
  </id_info>
  <brief_title>The Effects of Low Dose Ketamine on Cardiovascular Function</brief_title>
  <official_title>The Effects of Low Dose Ketamine on Cardiovascular Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <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>
      Low dose ketamine is used for pain management and for the treatment of anxiety and&#xD;
      depression. Prior studies on low dose ketamine have noted short-term (minutes to hours)&#xD;
      increases or decreases in blood pressure. Blood pressure that is too high or too low can be&#xD;
      problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure.&#xD;
      In fact, no prior studies have measured sympathetic nervous system activity after low dose&#xD;
      ketamine has been given to an adult. Because sympathetic nervous system activity has a large&#xD;
      influence on blood pressure, we need to know how exactly low dose ketamine affects these body&#xD;
      systems. Therefore, in this research we will study how low dose ketamine affects sympathetic&#xD;
      nervous system activity and cardiovascular function. The results from this research will&#xD;
      inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and&#xD;
      blood vessels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The focus of the laboratory went a different direction given extramural funding&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <phase>Phase 1</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>We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Sympathetic Nerve Activity Burst Frequency</measure>
    <time_frame>This outcome will be assessed within one trial lasting up to approximately five hours</time_frame>
    <description>We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial Blood Pressure</measure>
    <time_frame>This outcome will be assessed within one trial lasting up to approximately five hours</time_frame>
    <description>We will measure arterial blood pressure, quantified as systolic, mean, and/or diastolic pressure, using an automated monitor before and after administration of low dose ketamine.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Vessel Diameter</measure>
    <time_frame>This outcome will be assessed within one trial lasting up to approximately five hours</time_frame>
    <description>We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Low Dose Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline</description>
    <arm_group_label>Low Dose Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline (placebo)</intervention_name>
    <description>Saline (placebo)</description>
    <arm_group_label>Saline (placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-obese (body mass index less than 30 kg/m2)&#xD;
&#xD;
             *alternatively, individuals will be permitted to participate if they have a body mass&#xD;
             index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102&#xD;
             cm for males&#xD;
&#xD;
          -  Systolic blood pressure &lt;140 mmHg&#xD;
&#xD;
          -  Diastolic blood pressure &lt;90 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses&#xD;
&#xD;
          -  Current or previous use of anti-hypertensive medications&#xD;
&#xD;
          -  Any known history of renal or hepatic insufficiency/disease&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Current smokers, as well as individuals who regularly smoked within the past 3 years&#xD;
&#xD;
          -  Individuals with a history of drug abuse&#xD;
&#xD;
          -  Individuals who have an unexplained positive urine drug screen (e.g., some agents&#xD;
             cause false-positive results, but when the agent is abstained for hours/days/weeks,&#xD;
             the repeated drug screen is negative. One example could be an over-the-counter&#xD;
             supplement)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</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>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Craig Crandall</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04429685
org study id: STU-2019-1792
nct id: NCT04429685
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Low dose ketamine is used for pain management and for the treatment of anxiety and
      depression. Prior studies on low dose ketamine have noted short-term (minutes to hours)
      increases or decreases in blood pressure. Blood pressure that is too high or too low can be
      problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure.
      In fact, no prior studies have measured sympathetic nervous system activity after low dose
      ketamine has been given to an adult. Because sympathetic nervous system activity has a large
      influence on blood pressure, we need to know how exactly low dose ketamine affects these body
      systems. Therefore, in this research we will study how low dose ketamine affects sympathetic
      nervous system activity and cardiovascular function. The results from this research will
      inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and
      blood vessels.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Muscle Sympathetic Nerve Activity Burst Frequency
time frame: This outcome will be assessed within one trial lasting up to approximately five hours
description: We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography
measure: Arterial Blood Pressure
time frame: This outcome will be assessed within one trial lasting up to approximately five hours
description: We will measure arterial blood pressure, quantified as systolic, mean, and/or diastolic pressure, using an automated monitor before and after administration of low dose ketamine.
measure: Blood Vessel Diameter
time frame: This outcome will be assessed within one trial lasting up to approximately five hours
description: We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.
arm group label: Low Dose Ketamine
arm group type: Experimental
arm group label: Saline (placebo)
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Ketamine
description: Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
arm group label: Low Dose Ketamine
intervention type: Drug
intervention name: Saline (placebo)
description: Saline (placebo)
arm group label: Saline (placebo)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Craig Crandall
investigator title: Professor
mesh term: Ketamine
sharing ipd: Undecided