<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/NCT03010995</url>
  </required_header>
  <id_info>
    <org_study_id>16.1079</org_study_id>
    <nct_id>NCT03010995</nct_id>
  </id_info>
  <brief_title>The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study</brief_title>
  <acronym>ACE</acronym>
  <official_title>The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in&#xD;
      E-Cigarette users and also study the mechanism involved particularly with vascular&#xD;
      impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1&#xD;
      month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10&#xD;
      non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active&#xD;
      nicotine/tobacco or related product user) for a one study visit.The participants will be&#xD;
      asked to abstain from all tobacco/nicotine and related product use for 12 hours before each&#xD;
      visit.&#xD;
&#xD;
      Measurements will be taken at each study visit before and after E-cigarette use, each day&#xD;
      with different nicotine dose, to look at both the individuals' exposure to nicotine and also&#xD;
      the effects on the cardiovascular system. These measurements will include blood and urine&#xD;
      samples as well as non-invasive cardiovascular measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study discontinued due to lack of study funding.&#xD;
  </why_stopped>
  <start_date type="Actual">March 13, 2018</start_date>
  <completion_date type="Actual">July 24, 2018</completion_date>
  <primary_completion_date type="Actual">July 24, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>Change between baseline and post exposure 20-30 mins</time_frame>
    <description>Flow mediated dilatation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Change between baseline and post exposure 5,10, 30, 60, 120 mins</time_frame>
    <description>Heart rate monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change between baseline and post exposure 5,10, 30, 60, 120 mins</time_frame>
    <description>Blood pressure monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>Change between baseline and post exposure 20 mins</time_frame>
    <description>SphygmoCor HRV system SCOR-Hx</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nicotine levels in plasma</measure>
    <time_frame>Change between Baseline and over 2 hours</time_frame>
    <description>Detect plasma nicotine levels</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cigarette Smoking Toxicity</condition>
  <condition>Nicotine</condition>
  <condition>Acute Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>18 mg nicotine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>E-cigarette with 18 mg nicotine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>9 mg nicotine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>E-cigarette with 9 mg nicotine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 mg nicotine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>E-cigarette with 0 mg nicotine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prazosin</intervention_name>
    <description>Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes</description>
    <arm_group_label>0 mg nicotine</arm_group_label>
    <arm_group_label>18 mg nicotine</arm_group_label>
    <arm_group_label>9 mg nicotine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant will be currently healthy individuals, between 18 and 40 years of age.&#xD;
&#xD;
          2. E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco&#xD;
             cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their&#xD;
             lifetime and are not active nicotine/tobacco or related product users&#xD;
&#xD;
          3. Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to&#xD;
             study.&#xD;
&#xD;
          4. Do not meet any of the Exclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to provide informed consent.&#xD;
&#xD;
          2. Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including&#xD;
             fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ&#xD;
             transplant, renal replacement therapy, kidney disease or insufficiency, dialysis,&#xD;
             active cancer of any type, and untreated thyroid disease, major injury or trauma.&#xD;
&#xD;
          3. Body weight less than 100 pounds or BMI &gt;40.&#xD;
&#xD;
          4. Participants that are taking the following medications: estrogen, testosterone, anti&#xD;
             TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid,&#xD;
             rifampicin certain biologics, or Procrit&#xD;
&#xD;
          5. Participants that are currently using nicotine patches, nicotine gum or any form of&#xD;
             nicotine-containing cessation device&#xD;
&#xD;
          6. Pregnant or lactating women.&#xD;
&#xD;
          7. Prisoners and other vulnerable populations.&#xD;
&#xD;
          8. Anyone that PI thinks is unsafe to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Affan B. Irfan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>electronic cigarette</keyword>
  <keyword>endothelial function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prazosin</mesh_term>
  </intervention_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/NCT03010995
org study id: 16.1079
nct id: NCT03010995
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in
      E-Cigarette users and also study the mechanism involved particularly with vascular
      impairment.
We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1
      month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10
      non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active
      nicotine/tobacco or related product user) for a one study visit.The participants will be
      asked to abstain from all tobacco/nicotine and related product use for 12 hours before each
      visit.

      Measurements will be taken at each study visit before and after E-cigarette use, each day
      with different nicotine dose, to look at both the individuals' exposure to nicotine and also
      the effects on the cardiovascular system. These measurements will include blood and urine
      samples as well as non-invasive cardiovascular measurements.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.
measure: Endothelial function
time frame: Change between baseline and post exposure 20-30 mins
description: Flow mediated dilatation
measure: Heart rate
time frame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
description: Heart rate monitor
measure: Blood pressure
time frame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
description: Blood pressure monitor
measure: Heart Rate Variability
time frame: Change between baseline and post exposure 20 mins
description: SphygmoCor HRV system SCOR-Hx
measure: Nicotine levels in plasma
time frame: Change between Baseline and over 2 hours
description: Detect plasma nicotine levels
arm group label: 18 mg nicotine
arm group type: Active Comparator
description: E-cigarette with 18 mg nicotine
arm group label: 9 mg nicotine
arm group type: Active Comparator
description: E-cigarette with 9 mg nicotine
arm group label: 0 mg nicotine
arm group type: Placebo Comparator
description: E-cigarette with 0 mg nicotine
intervention type: Drug
intervention name: Prazosin
description: Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
arm group label: 0 mg nicotine
arm group label: 18 mg nicotine
arm group label: 9 mg nicotine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Affan B. Irfan
investigator title: Principal investigator
mesh term: Cardiovascular Diseases
mesh term: Prazosin
sharing ipd: No