<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/NCT02185898</url>
  </required_header>
  <id_info>
    <org_study_id>CSD1302</org_study_id>
    <nct_id>NCT02185898</nct_id>
  </id_info>
  <brief_title>Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes</brief_title>
  <official_title>A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R.J. Reynolds Vapor Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>R.J. Reynolds Tobacco Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>MAS (Materials Analytical Services), LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>R.J. Reynolds Vapor Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess environmental emissions of selected compounds in a test chamber after&#xD;
      cigarette smoking or e-cigarette vaping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and&#xD;
      sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different&#xD;
      from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with&#xD;
      common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and&#xD;
      secondhand vapor from e-cigarettes.&#xD;
&#xD;
      The goals of this study are to 1) increase understanding of the composition of SHS from&#xD;
      e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a&#xD;
      market sample of commercial e-cigarettes to leading brand styles of commercial&#xD;
      tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including&#xD;
      the market-sample e-cigarettes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes.</measure>
    <time_frame>2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine selected SHS constituent emission factors for each tobacco-burning cigarette, each e-cigarette, and the market-sample e-cigarettes (collectively).</measure>
    <time_frame>2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes and tobacco-burning cigarettes compared to after a non-smoking blank condition.</measure>
    <time_frame>2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess differences in levels of additional selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes compared to after human smoking of tobacco-burning cigarettes.</measure>
    <time_frame>2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Leading U.S. tobacco-burning non-menthol cigarette</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Leading U.S. non-menthol cigarette</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leading U.S. tobacco-burning menthol cigarette</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Leading U.S. menthol cigarette</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic cigarette #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VUSE® (menthol flavor, 29 mg nicotine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic cigarette #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VUSE® (original flavor, 29 mg nicotine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic cigarette #3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VUSE® (original flavor, 14 mg nicotine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>U.S. Market-sample electronic cigarettes (two brands)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ (any variety) and NJOY® (any variety)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leading U.S. non-menthol cigarette</intervention_name>
    <description>Tobacco-burning non-menthol cigarette</description>
    <arm_group_label>Leading U.S. tobacco-burning non-menthol cigarette</arm_group_label>
    <other_name>Marlboro Gold Pack Box</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leading U.S. menthol cigarette</intervention_name>
    <description>Tobacco-burning menthol cigarette</description>
    <arm_group_label>Leading U.S. tobacco-burning menthol cigarette</arm_group_label>
    <other_name>Newport Box</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic cigarette #1</intervention_name>
    <description>Electronic cigarette</description>
    <arm_group_label>Electronic cigarette #1</arm_group_label>
    <other_name>VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic cigarette #2</intervention_name>
    <description>Electronic cigarette</description>
    <arm_group_label>Electronic cigarette #2</arm_group_label>
    <other_name>VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic cigarette #3</intervention_name>
    <description>Electronic cigarette</description>
    <arm_group_label>Electronic cigarette #3</arm_group_label>
    <other_name>VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>U.S. Market-sample electronic cigarettes</intervention_name>
    <description>Marketed electronic cigarettes</description>
    <arm_group_label>U.S. Market-sample electronic cigarettes (two brands)</arm_group_label>
    <other_name>blu™ (any variety) and NJOY® (any variety)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and&#xD;
             complete questionnaires written in English.&#xD;
&#xD;
          2. Generally healthy males or females, 21 years of age or older at Screening.&#xD;
&#xD;
          3. Able to meet cohort-specific requirements as follows:&#xD;
&#xD;
             Cohort 1 - Leading U.S. tobacco-burning non-menthol cigarette, and&#xD;
&#xD;
             Cohort 2 - Leading U.S. tobacco-burning menthol cigarette:&#xD;
&#xD;
               -  self-reports at the Screening Visit smoking at least 5 cigarettes per day and&#xD;
                  inhaling the smoke, for at least 3 months prior to Screening&#xD;
&#xD;
               -  self-reports smoking Leading U.S. tobacco-burning non-menthol cigarette or&#xD;
                  Leading U.S. tobacco-burning menthol cigarette as usual brand (UB) cigarettes [UB&#xD;
                  cigarette is defined as the cigarette brand style currently smoked most&#xD;
                  frequently by the participant];&#xD;
&#xD;
             Cohort 3 - Electronic cigarette #1 smokers, and&#xD;
&#xD;
             Cohort 4 - Electronic cigarette #2 smokers:&#xD;
&#xD;
               -  self-reports at the Screening Visit smoking a non-menthol e-cigarette at least&#xD;
                  once per day, for at least 3 months prior to Screening;&#xD;
&#xD;
               -  willing to switch from using their current e-cigarette brand style to using a&#xD;
                  different e-cigarette brand style during the study;&#xD;
&#xD;
             Cohort 5 - Electronic cigarette #3 smokers:&#xD;
&#xD;
               -  self-reports at the Screening Visit smoking a menthol e-cigarette at least once&#xD;
                  per day, for at least 3 months prior to Screening;&#xD;
&#xD;
               -  willing to switch from using their current e-cigarette brand style to using a&#xD;
                  different e-cigarette brand style during the study;&#xD;
&#xD;
             Cohort 6 - U.S Market-sample electronic cigarette smokers:&#xD;
&#xD;
               -  self-reports at the Screening Visit smoking the selected U.S. market-sample&#xD;
                  e-cigarettes (menthol or non-menthol) at least once per day, for at least three&#xD;
                  months prior to Screening;&#xD;
&#xD;
               -  willing to continue exclusive use of their preferred style (flavor) of&#xD;
                  e-cigarette during the study.&#xD;
&#xD;
          4. Females of childbearing potential must be willing to use a form of contraception&#xD;
             acceptable to the Investigator from the time of signing informed consent until study&#xD;
             discharge or be surgically sterile for at least 90 days prior to enrollment;&#xD;
&#xD;
          5. Able to safely perform the required study procedures, as determined by the&#xD;
             Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at&#xD;
             Screening, as determined by the Investigator, that would preclude a participant from&#xD;
             participating safely in the study (e.g., hypertension, asthma, or other lung disease;&#xD;
             cardiac disease; neurological disease; or psychiatric disorders) based on screening&#xD;
             assessments such as safety labs and medical history or physical examination at&#xD;
             Enrollment;&#xD;
&#xD;
          2. Self-reports or safety labs indicate diabetes;&#xD;
&#xD;
          3. At risk for heart disease, as determined by the Investigator;&#xD;
&#xD;
          4. Use of medicine for treatment of depression or asthma;&#xD;
&#xD;
          5. Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg,&#xD;
             measured after being seated for 5 minutes;&#xD;
&#xD;
          6. Postponing a decision to quit smoking (defined as planning a quit attempt within 30&#xD;
             days of the Screening Visit) to participate in this study;&#xD;
&#xD;
          7. Employed by a tobacco company, the study site, or environmental test chamber vendor;&#xD;
&#xD;
          8. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to&#xD;
             become pregnant during the course of the study;&#xD;
&#xD;
          9. History of claustrophobia;&#xD;
&#xD;
         10. Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart&#xD;
             employee);&#xD;
&#xD;
         11. Determined by the Investigator to be inappropriate for this study, including a&#xD;
             participant who is unable to communicate or unwilling to cooperate with the clinical&#xD;
             staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Segall, MD, CPI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Atlanta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Atlanta</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electronic cigarettes</keyword>
  <keyword>e-cigarettes</keyword>
  <keyword>combustible cigarettes</keyword>
  <keyword>second-hand smoke</keyword>
  <keyword>environmental tobacco smoke</keyword>
  <keyword>tobacco-burning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
    <mesh_term>Nicotine</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/NCT02185898
org study id: CSD1302
nct id: NCT02185898
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will assess environmental emissions of selected compounds in a test chamber after
      cigarette smoking or e-cigarette vaping.
Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and
      sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different
      from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with
      common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and
      secondhand vapor from e-cigarettes.

      The goals of this study are to 1) increase understanding of the composition of SHS from
      e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a
      market sample of commercial e-cigarettes to leading brand styles of commercial
      tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including
      the market-sample e-cigarettes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes.
time frame: 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
measure: To determine selected SHS constituent emission factors for each tobacco-burning cigarette, each e-cigarette, and the market-sample e-cigarettes (collectively).
time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
measure: To assess the differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes and tobacco-burning cigarettes compared to after a non-smoking blank condition.
time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
measure: To assess differences in levels of additional selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes compared to after human smoking of tobacco-burning cigarettes.
time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
arm group label: Leading U.S. tobacco-burning non-menthol cigarette
arm group type: Active Comparator
description: Leading U.S. non-menthol cigarette
arm group label: Leading U.S. tobacco-burning menthol cigarette
arm group type: Active Comparator
description: Leading U.S. menthol cigarette
arm group label: Electronic cigarette #1
arm group type: Experimental
description: VUSE® (menthol flavor, 29 mg nicotine)
arm group label: Electronic cigarette #2
arm group type: Experimental
description: VUSE® (original flavor, 29 mg nicotine)
arm group label: Electronic cigarette #3
arm group type: Experimental
description: VUSE® (original flavor, 14 mg nicotine)
arm group label: U.S. Market-sample electronic cigarettes (two brands)
arm group type: Experimental
description: blu™ (any variety) and NJOY® (any variety)
intervention type: Other
intervention name: Leading U.S. non-menthol cigarette
description: Tobacco-burning non-menthol cigarette
arm group label: Leading U.S. tobacco-burning non-menthol cigarette
other name: Marlboro Gold Pack Box
intervention type: Other
intervention name: Leading U.S. menthol cigarette
description: Tobacco-burning menthol cigarette
arm group label: Leading U.S. tobacco-burning menthol cigarette
other name: Newport Box
intervention type: Other
intervention name: Electronic cigarette #1
description: Electronic cigarette
arm group label: Electronic cigarette #1
other name: VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)
intervention type: Other
intervention name: Electronic cigarette #2
description: Electronic cigarette
arm group label: Electronic cigarette #2
other name: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)
intervention type: Other
intervention name: Electronic cigarette #3
description: Electronic cigarette
arm group label: Electronic cigarette #3
other name: VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)
intervention type: Other
intervention name: U.S. Market-sample electronic cigarettes
description: Marketed electronic cigarettes
arm group label: U.S. Market-sample electronic cigarettes (two brands)
other name: blu™ (any variety) and NJOY® (any variety)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathan Segall, MD, CPI
role: Principal Investigator
affiliation: Clinical Research Atlanta
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
mesh term: Menthol
mesh term: Nicotine
sharing ipd: No