<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/NCT03823885</url>
  </required_header>
  <id_info>
    <org_study_id>18001147</org_study_id>
    <nct_id>NCT03823885</nct_id>
  </id_info>
  <brief_title>ECigs, Inflammation and Oxidative Stress</brief_title>
  <official_title>E-Cigarettes and Monocytes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tobacco Related Disease Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress&#xD;
      and inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig&#xD;
      (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for&#xD;
      biomarkers of inflammation and oxidative stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">October 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 8, 2023</primary_completion_date>
  <phase>N/A</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>Crossover with 2 week washout</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Code</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cellular Reactive Oxygen Species, units = % fluorescence</measure>
    <time_frame>within 4 hours of E-cig use</time_frame>
    <description>cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD 14+ Monocyte, units = % of total cells</measure>
    <time_frame>within 4 hours of e-cig use</time_frame>
    <description>CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>E-cigarettes, Oxidative Stress, Inflammation</condition>
  <arm_group>
    <arm_group_label>E-cig</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One time exposure to e-cig</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One time exposure to empty e-cig</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>e-cigarette</intervention_name>
    <description>use e-cig for 30 minutes</description>
    <arm_group_label>E-cig</arm_group_label>
    <other_name>e-cig</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>empty (-cigarette sham control)</intervention_name>
    <description>use empty e-cig (sham control)</description>
    <arm_group_label>sham</arm_group_label>
    <other_name>empty e-cig</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac disease Respiratory disease Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Holly R Middlekauff, MD</last_name>
    <phone>310-206-6672</phone>
    <email>hmiddlekauff@mednet.ucla.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karishma Lakhani, BA</last_name>
      <phone>310-825-3510</phone>
      <email>klakhani@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Holly R Middlekauff, MD</last_name>
      <phone>310-206-6672</phone>
      <email>hmiddlekauff@mednet.ucla.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 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>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Holly R Middlekauff</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03823885
org study id: 18001147
nct id: NCT03823885
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress
      and inflammation.
Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig
      (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for
      biomarkers of inflammation and oxidative stress.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover with 2 week washout
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
masking description: Code
measure: Cellular Reactive Oxygen Species, units = % fluorescence
time frame: within 4 hours of E-cig use
description: cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
measure: CD 14+ Monocyte, units = % of total cells
time frame: within 4 hours of e-cig use
description: CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye
arm group label: E-cig
arm group type: Experimental
description: One time exposure to e-cig
arm group label: sham
arm group type: Experimental
description: One time exposure to empty e-cig
intervention type: Other
intervention name: e-cigarette
description: use e-cig for 30 minutes
arm group label: E-cig
other name: e-cig
intervention type: Other
intervention name: empty (-cigarette sham control)
description: use empty e-cig (sham control)
arm group label: sham
other name: empty e-cig
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Holly R Middlekauff, MD
phone: 310-206-6672
email: hmiddlekauff@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Holly R Middlekauff
investigator title: Principal Investigator
mesh term: Inflammation
sharing ipd: No