<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/NCT03830892</url>
  </required_header>
  <id_info>
    <org_study_id>HM20012696</org_study_id>
    <secondary_id>2U54DA036105</secondary_id>
    <nct_id>NCT03830892</nct_id>
  </id_info>
  <brief_title>Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers</brief_title>
  <official_title>Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      This study aims to understand the effects of device power and nicotine concentration on the&#xD;
      likelihood that someone would use or abuse e-cigarettes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated due to COVID&#xD;
  </why_stopped>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">March 6, 2020</completion_date>
  <primary_completion_date type="Actual">March 6, 2020</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>We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes.&#xD;
All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette.&#xD;
The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Breakpoint of Drug Purchase Tasks (DPT)</measure>
    <time_frame>Up to 180 minutes</time_frame>
    <description>The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breakpoint of Multiple Choice Procedure (MCP)</measure>
    <time_frame>Up to 180 minutes.</time_frame>
    <description>The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effort for Product Puffs With the Progressive Ratio Task (PRT)</measure>
    <time_frame>Up to 180 minutes.</time_frame>
    <description>The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Subjective Measures of Nicotine Abstinence Symptoms</measure>
    <time_frame>First measure given, regardless of task order, 90 minutes into each session</time_frame>
    <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective Measures of Nicotine Abstinence Symptoms</measure>
    <time_frame>Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
    <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective Measures of Nicotine Abstinence Symptoms</measure>
    <time_frame>Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
    <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective Measures of Nicotine Abstinence Symptoms</measure>
    <time_frame>Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
    <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Heart Rate</measure>
    <time_frame>Recorded throughout each 4 hour study session using automated software every 10 seconds.</time_frame>
    <description>Heart rate (measured in bpm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>Recorded throughout each 4 hour study session using automated software every 5 minutes.</time_frame>
    <description>Blood pressure (measured in mm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Diastolic Blood Pressure</measure>
    <time_frame>Recorded throughout each 4 hour study session using automated software every 5 minutes.</time_frame>
    <description>and blood pressure (measured in hg)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Electronic Cigarettes</condition>
  <arm_group>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette Lab Session 15 watts, 10 mg nicotine</intervention_name>
    <description>E-cigarette paired with low nicotine, low device power</description>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette Lab Session 15 watts, 30 mg nicotine</intervention_name>
    <description>E-cigarette paired with low nicotine, low device power</description>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette Lab Session 30 watts, 10 mg nicotine</intervention_name>
    <description>E-cigarette paired with low nicotine, low device power</description>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette Lab Session 30 watts, 30 mg nicotine</intervention_name>
    <description>E-cigarette paired with low nicotine, low device power</description>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Own Brand Session - E-cigarette</intervention_name>
    <description>E-cigarette paired with own brand liquid and preferred power</description>
    <arm_group_label>Dual User</arm_group_label>
    <arm_group_label>E-cigarette User (Exclusive)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Own Brand Session - E-cigarette/Cigarette</intervention_name>
    <description>Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
    <arm_group_label>Dual User</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy (determined by self-report)&#xD;
&#xD;
          -  between the ages of 21-55&#xD;
&#xD;
          -  willing to provide informed consent&#xD;
&#xD;
          -  able to attend the lab and abstain from tobacco/nicotine as required and must agree to&#xD;
             use designated products according to study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at&#xD;
             screening.&#xD;
&#xD;
        Some study details about the eligibility criteria are purposely omitted at this time to&#xD;
        preserve scientific integrity. Full details will be posted at the conclusion of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Cobb (Amey), PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Barnes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for the Study of Tobacco Products</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>March 16, 2021</results_first_submitted>
  <results_first_submitted_qc>May 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2021</results_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03830892/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03830892/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03830892/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Each participant will participate in 6 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>E-cigarette User (Exclusive)</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
        </group>
        <group group_id="P2">
          <title>Dual User</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>15 Watts, 10 mg Nicotine</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>15 Watts, 30 mg Nicotine</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>30 Watts, 10 mg Nicotine</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>30 Watts, 30 mg Nicotine</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Own Brand</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated due to COVID</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants due to the protocol changes.</population>
      <group_list>
        <group group_id="B1">
          <title>E-cigarette User (Exclusive)</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
        </group>
        <group group_id="B2">
          <title>Dual User</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.53" spread="7.53"/>
                    <measurement group_id="B2" value="29" spread="6.84"/>
                    <measurement group_id="B3" value="28.13" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle Eastern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Breakpoint of Drug Purchase Tasks (DPT)</title>
        <description>The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
        <time_frame>Up to 180 minutes</time_frame>
        <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
        <group_list>
          <group group_id="O1">
            <title>E-cigarette User (Exclusive)</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
          </group>
          <group group_id="O2">
            <title>Dual User</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
          </group>
        </group_list>
        <measure>
          <title>Breakpoint of Drug Purchase Tasks (DPT)</title>
          <description>The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
          <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
          <units>US Dollars</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>own brand e-cigarette</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="3.59"/>
                    <measurement group_id="O2" value="3.79" spread="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="3.73"/>
                    <measurement group_id="O2" value="4.43" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" spread="3.41"/>
                    <measurement group_id="O2" value="4.26" spread="3.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread="3.43"/>
                    <measurement group_id="O2" value="4.23" spread="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="3.50"/>
                    <measurement group_id="O2" value="4.80" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Breakpoint of Multiple Choice Procedure (MCP)</title>
        <description>The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
        <time_frame>Up to 180 minutes.</time_frame>
        <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
        <group_list>
          <group group_id="O1">
            <title>E-cigarette User (Exclusive)</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
          </group>
          <group group_id="O2">
            <title>Dual User</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
          </group>
        </group_list>
        <measure>
          <title>Breakpoint of Multiple Choice Procedure (MCP)</title>
          <description>The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
          <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
          <units>US Dollars</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Own brand e-cigarette</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="2.92"/>
                    <measurement group_id="O2" value="2.90" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.51" spread="3.18"/>
                    <measurement group_id="O2" value="2.36" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="2.93"/>
                    <measurement group_id="O2" value="2.51" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="2.98"/>
                    <measurement group_id="O2" value="2.10" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="2.13"/>
                    <measurement group_id="O2" value="2.23" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effort for Product Puffs With the Progressive Ratio Task (PRT)</title>
        <description>The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
        <time_frame>Up to 180 minutes.</time_frame>
        <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
        <group_list>
          <group group_id="O1">
            <title>E-cigarette User (Exclusive)</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
          </group>
          <group group_id="O2">
            <title>Dual User</title>
            <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
          </group>
        </group_list>
        <measure>
          <title>Effort for Product Puffs With the Progressive Ratio Task (PRT)</title>
          <description>The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).</description>
          <population>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.</population>
          <units>e-cigarette puffs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>own brand e-cigarette</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.95" spread="1.54"/>
                    <measurement group_id="O2" value="4.54" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.74" spread="1.88"/>
                    <measurement group_id="O2" value="4.54" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 30 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" spread="1.77"/>
                    <measurement group_id="O2" value="4.38" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.58" spread="1.68"/>
                    <measurement group_id="O2" value="5.38" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 watts, 10 mg/ml nicotine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.89" spread="1.59"/>
                    <measurement group_id="O2" value="4.77" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Measures of Nicotine Abstinence Symptoms</title>
        <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
        <time_frame>First measure given, regardless of task order, 90 minutes into each session</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Measures of Nicotine Abstinence Symptoms</title>
        <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
        <time_frame>Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Measures of Nicotine Abstinence Symptoms</title>
        <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
        <time_frame>Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Measures of Nicotine Abstinence Symptoms</title>
        <description>Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.</description>
        <time_frame>Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Heart Rate</title>
        <description>Heart rate (measured in bpm)</description>
        <time_frame>Recorded throughout each 4 hour study session using automated software every 10 seconds.</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Systolic Blood Pressure</title>
        <description>Blood pressure (measured in mm)</description>
        <time_frame>Recorded throughout each 4 hour study session using automated software every 5 minutes.</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Diastolic Blood Pressure</title>
        <description>and blood pressure (measured in hg)</description>
        <time_frame>Recorded throughout each 4 hour study session using automated software every 5 minutes.</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.</time_frame>
      <desc>Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.&#xD;
All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.</desc>
      <group_list>
        <group group_id="E1">
          <title>E-cigarette User (Exclusive)</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power</description>
        </group>
        <group group_id="E2">
          <title>Dual User</title>
          <description>Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette&#xD;
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power&#xD;
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power&#xD;
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Unrelated hospitalization</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Andrew J. Barnes</name_or_title>
      <organization>Virginia Commonwealth University</organization>
      <phone>804-827-4361</phone>
      <email>abarnes3@vcu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03830892
org study id: HM20012696
secondary id: 2U54DA036105
nct id: NCT03830892
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to understand the effects of device power and nicotine concentration on the
      likelihood that someone would use or abuse e-cigarettes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes.
All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette.
The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.
primary purpose: Basic Science
masking: Single (Participant)
masking description: Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.
measure: Breakpoint of Drug Purchase Tasks (DPT)
time frame: Up to 180 minutes
description: The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
measure: Breakpoint of Multiple Choice Procedure (MCP)
time frame: Up to 180 minutes.
description: The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
measure: Effort for Product Puffs With the Progressive Ratio Task (PRT)
time frame: Up to 180 minutes.
description: The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
measure: Subjective Measures of Nicotine Abstinence Symptoms
time frame: First measure given, regardless of task order, 90 minutes into each session
description: Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
measure: Subjective Measures of Nicotine Abstinence Symptoms
time frame: Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
description: Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
measure: Subjective Measures of Nicotine Abstinence Symptoms
time frame: Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
description: Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
measure: Subjective Measures of Nicotine Abstinence Symptoms
time frame: Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
description: Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
measure: Change in Heart Rate
time frame: Recorded throughout each 4 hour study session using automated software every 10 seconds.
description: Heart rate (measured in bpm)
measure: Change in Systolic Blood Pressure
time frame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
description: Blood pressure (measured in mm)
measure: Change in Diastolic Blood Pressure
time frame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
description: and blood pressure (measured in hg)
arm group label: E-cigarette User (Exclusive)
arm group type: Active Comparator
description: Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
arm group label: Dual User
arm group type: Active Comparator
description: Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
intervention type: Other
intervention name: E-cigarette Lab Session 15 watts, 10 mg nicotine
description: E-cigarette paired with low nicotine, low device power
arm group label: Dual User
arm group label: E-cigarette User (Exclusive)
intervention type: Other
intervention name: E-cigarette Lab Session 15 watts, 30 mg nicotine
description: E-cigarette paired with low nicotine, low device power
arm group label: Dual User
arm group label: E-cigarette User (Exclusive)
intervention type: Other
intervention name: E-cigarette Lab Session 30 watts, 10 mg nicotine
description: E-cigarette paired with low nicotine, low device power
arm group label: Dual User
arm group label: E-cigarette User (Exclusive)
intervention type: Other
intervention name: E-cigarette Lab Session 30 watts, 30 mg nicotine
description: E-cigarette paired with low nicotine, low device power
arm group label: Dual User
arm group label: E-cigarette User (Exclusive)
intervention type: Other
intervention name: Own Brand Session - E-cigarette
description: E-cigarette paired with own brand liquid and preferred power
arm group label: Dual User
arm group label: E-cigarette User (Exclusive)
intervention type: Other
intervention name: Own Brand Session - E-cigarette/Cigarette
description: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
arm group label: Dual User
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Cobb (Amey), PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
last name: Andrew Barnes, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
sharing ipd: Undecided
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 