<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/NCT03011710</url>
  </required_header>
  <id_info>
    <org_study_id>epidacute-ecig-2015</org_study_id>
    <nct_id>NCT03011710</nct_id>
  </id_info>
  <brief_title>Epidemiology and Acute Oral Effects Electronic Cigarette</brief_title>
  <official_title>Epidemiology and Acute Oral Effects of Electronic Cigarette</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Semmelweis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco&#xD;
      smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently&#xD;
      referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use&#xD;
      and awareness of these devices has grown exponentially in recent years, with millions of&#xD;
      people currently using them.&#xD;
&#xD;
      The benefits and risks of electronic cigarette use are uncertain. There is no research on the&#xD;
      acute oral effects of electronic cigarette in the scientific literature and no hungarian&#xD;
      epidemiological survey has been performed in this topic.&#xD;
&#xD;
      Regulation of electronic cigarettes varies across countries in the European Union, ranging&#xD;
      from no regulation to banning them entirely.&#xD;
&#xD;
      The investigators research could help to integrate the regulation of this device in Hungary&#xD;
      and in the EU as well.&#xD;
&#xD;
      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey&#xD;
      would be novel in this topic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The epidemiological survey is performed with online questionnaires, which are published on&#xD;
      e-cigarette-selling websites and on other forums dealing with this topic.&#xD;
&#xD;
      The main outcome of interest was whether or not e-cigarette use helped people to quit smoking&#xD;
      or reduce the number of conventional cigarettes. Participants were also asked about the&#xD;
      reason for starting e-cigarette use. Nationality, habitation, citizenship status were&#xD;
      included as demographic predictors in analyses.&#xD;
&#xD;
      Measurements of acute oral effects before and after using electronic cigarette with nicotine,&#xD;
      without nicotine, conventional cigarette and placebo device:&#xD;
&#xD;
        -  measurement of exhaled CO changes by Smokerlyzer piCO&#xD;
&#xD;
        -  measurement of saliva MMP-8 by PerioSafe Home&#xD;
&#xD;
        -  measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check&#xD;
           Buffer Kit (GC)&#xD;
&#xD;
        -  measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution&#xD;
           (LASCA method)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2015</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in blood flow after vaping/smoking</measure>
    <time_frame>baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping</time_frame>
    <description>The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Nicotine Dependence, Cigarettes</condition>
  <arm_group>
    <arm_group_label>E-cigarette with nicotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nicotine level: 6 mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette without nicotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nicotine level: 0 mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional cigarette</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nicotine content: 0,5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cigarette tip</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProVari v2.5 (E-cigarette)</intervention_name>
    <description>An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.</description>
    <arm_group_label>E-cigarette with nicotine</arm_group_label>
    <arm_group_label>E-cigarette without nicotine</arm_group_label>
    <other_name>ProVari v2.5</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Marlboro Gold (Conventional cigarette)</intervention_name>
    <description>Conventional cigarette</description>
    <arm_group_label>Conventional cigarette</arm_group_label>
    <other_name>Marlboro Gold 0,6mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cigarette tip</intervention_name>
    <description>Placebo device</description>
    <arm_group_label>Cigarette tip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 19-49 years&#xD;
&#xD;
          -  signed consent form&#xD;
&#xD;
          -  smoking regularly e-cigarette and/or conventional cigarette for &gt; half year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not pregnant and not planning pregnancy in the next 6 month&#xD;
&#xD;
          -  BMI index &lt; 30&#xD;
&#xD;
          -  no severe parodontal disease&#xD;
&#xD;
          -  no acute illness in the last 2 weeks&#xD;
&#xD;
          -  no chronic disease (eg.: diabetes)&#xD;
&#xD;
          -  no diet which can influence the oral pH&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>e-cigarette</keyword>
  <keyword>blood flow</keyword>
  <keyword>oral effects</keyword>
  <keyword>oral pH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</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/NCT03011710
org study id: epidacute-ecig-2015
nct id: NCT03011710
lead sponsor: 
has dmc: No
Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco
      smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently
      referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use
      and awareness of these devices has grown exponentially in recent years, with millions of
      people currently using them.

      The benefits and risks of electronic cigarette use are uncertain. There is no research on the
      acute oral effects of electronic cigarette in the scientific literature and no hungarian
      epidemiological survey has been performed in this topic.

      Regulation of electronic cigarettes varies across countries in the European Union, ranging
      from no regulation to banning them entirely.

      The investigators research could help to integrate the regulation of this device in Hungary
      and in the EU as well.

      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey
      would be novel in this topic.
The epidemiological survey is performed with online questionnaires, which are published on
      e-cigarette-selling websites and on other forums dealing with this topic.

      The main outcome of interest was whether or not e-cigarette use helped people to quit smoking
      or reduce the number of conventional cigarettes. Participants were also asked about the
      reason for starting e-cigarette use. Nationality, habitation, citizenship status were
      included as demographic predictors in analyses.

      Measurements of acute oral effects before and after using electronic cigarette with nicotine,
      without nicotine, conventional cigarette and placebo device:

        -  measurement of exhaled CO changes by Smokerlyzer piCO

        -  measurement of saliva MMP-8 by PerioSafe Home

        -  measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check
           Buffer Kit (GC)

        -  measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution
           (LASCA method)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline in blood flow after vaping/smoking
time frame: baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping
description: The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.
arm group label: E-cigarette with nicotine
arm group type: Experimental
description: Nicotine level: 6 mg/ml
arm group label: E-cigarette without nicotine
arm group type: Experimental
description: Nicotine level: 0 mg/ml
arm group label: Conventional cigarette
arm group type: Experimental
description: Nicotine content: 0,5mg
arm group label: Cigarette tip
arm group type: Placebo Comparator
description: Placebo device
intervention type: Device
intervention name: ProVari v2.5 (E-cigarette)
description: An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.
arm group label: E-cigarette with nicotine
arm group label: E-cigarette without nicotine
other name: ProVari v2.5
intervention type: Device
intervention name: Marlboro Gold (Conventional cigarette)
description: Conventional cigarette
arm group label: Conventional cigarette
other name: Marlboro Gold 0,6mg
intervention type: Device
intervention name: Cigarette tip
description: Placebo device
arm group label: Cigarette tip
criteria: 
gender: All
minimum age: 19 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: No