<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/NCT03826303</url>
  </required_header>
  <id_info>
    <org_study_id>HM20015064</org_study_id>
    <secondary_id>2018-75-CX-0036</secondary_id>
    <nct_id>NCT03826303</nct_id>
  </id_info>
  <brief_title>The Impact of Vaping Ethanol in the Evaluation of Impairment</brief_title>
  <official_title>The Impact of Vaping Ethanol in the Evaluation of Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Justice</agency>
      <agency_class>U.S. Fed</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>
      The purpose of this research study is to find out about ethanol-containing e-cigarettes&#xD;
      impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a&#xD;
      common part of e-cigarette liquids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2021</start_date>
  <completion_date type="Actual">April 8, 2022</completion_date>
  <primary_completion_date type="Actual">April 8, 2022</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preliminary breath test for ethanol</measure>
    <time_frame>Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)</time_frame>
    <description>Initial type of breath test used (gives percent blood alcohol concentration)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evidentiary breath test for ethanol</measure>
    <time_frame>Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)</time_frame>
    <description>Secondary type of breath test used (gives percent blood alcohol concentration)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Field Sobriety Test</measure>
    <time_frame>Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)</time_frame>
    <description>Test used to determine sobriety</description>
  </primary_outcome>
  <other_outcome>
    <measure>Direct Effects of Vaping Questionnaire</measure>
    <time_frame>Administered after e-cigarette use (at 39 minutes after e-cigarette use)</time_frame>
    <description>Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)</description>
  </other_outcome>
  <other_outcome>
    <measure>Biphasic Alcohol Effects Scale</measure>
    <time_frame>Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)</time_frame>
    <description>Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)</description>
  </other_outcome>
  <other_outcome>
    <measure>General Labeled Magnitude Scale</measure>
    <time_frame>Administered after e-cigarette use (at 39 minutes after e-cigarette use)</time_frame>
    <description>Questionnaire that asks participants about flavor sensation, harshness/irritancy, and &quot;throat hit&quot; of the e-cigarette (3 questions, each scored from 0 - 100)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Electronic Cigarette Use</condition>
  <arm_group>
    <arm_group_label>E-cigarette with ethanol, 1 puff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette without ethanol, 1 puff</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette with ethanol, 10 puffs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette without ethanol, 10 puffs</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette liquid with ethanol, 1 puff</intervention_name>
    <description>E-cigarette liquid with ethanol, 1 puff</description>
    <arm_group_label>E-cigarette with ethanol, 1 puff</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette liquid without ethanol, 1 puff</intervention_name>
    <description>E-cigarette liquid without ethanol, 1 puff</description>
    <arm_group_label>E-cigarette without ethanol, 1 puff</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette liquid with ethanol, 10 puffs</intervention_name>
    <description>E-cigarette liquid with ethanol, 10 puffs</description>
    <arm_group_label>E-cigarette with ethanol, 10 puffs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette liquid without ethanol, 10 puffs</intervention_name>
    <description>E-cigarette liquid without ethanol, 10 puffs</description>
    <arm_group_label>E-cigarette without ethanol, 10 puffs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals must be e-cigarette users who are 21-65, willing to provide informed&#xD;
             consent, attend the lab sessions as needed. Participants must agree to use designated&#xD;
             products according to study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women will be excluded if they are breast-feeding or test positive for pregnancy (by&#xD;
             urinalysis) at screening.&#xD;
&#xD;
          -  Some study details about the eligibility criteria are purposely omitted at this time&#xD;
             to preserve scientific integrity. Full details will be posted at the conclusion of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Breland, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</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>Ethanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>September 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03826303/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03826303
org study id: HM20015064
secondary id: 2018-75-CX-0036
nct id: NCT03826303
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to find out about ethanol-containing e-cigarettes
      impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a
      common part of e-cigarette liquids.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Preliminary breath test for ethanol
time frame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)
description: Initial type of breath test used (gives percent blood alcohol concentration)
measure: Evidentiary breath test for ethanol
time frame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)
description: Secondary type of breath test used (gives percent blood alcohol concentration)
measure: Standard Field Sobriety Test
time frame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)
description: Test used to determine sobriety
measure: Direct Effects of Vaping Questionnaire
time frame: Administered after e-cigarette use (at 39 minutes after e-cigarette use)
description: Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)
measure: Biphasic Alcohol Effects Scale
time frame: Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)
description: Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)
measure: General Labeled Magnitude Scale
time frame: Administered after e-cigarette use (at 39 minutes after e-cigarette use)
description: Questionnaire that asks participants about flavor sensation, harshness/irritancy, and "throat hit" of the e-cigarette (3 questions, each scored from 0 - 100)
arm group label: E-cigarette with ethanol, 1 puff
arm group type: Experimental
arm group label: E-cigarette without ethanol, 1 puff
arm group type: Placebo Comparator
arm group label: E-cigarette with ethanol, 10 puffs
arm group type: Experimental
arm group label: E-cigarette without ethanol, 10 puffs
arm group type: Placebo Comparator
intervention type: Other
intervention name: E-cigarette liquid with ethanol, 1 puff
description: E-cigarette liquid with ethanol, 1 puff
arm group label: E-cigarette with ethanol, 1 puff
intervention type: Other
intervention name: E-cigarette liquid without ethanol, 1 puff
description: E-cigarette liquid without ethanol, 1 puff
arm group label: E-cigarette without ethanol, 1 puff
intervention type: Other
intervention name: E-cigarette liquid with ethanol, 10 puffs
description: E-cigarette liquid with ethanol, 10 puffs
arm group label: E-cigarette with ethanol, 10 puffs
intervention type: Other
intervention name: E-cigarette liquid without ethanol, 10 puffs
description: E-cigarette liquid without ethanol, 10 puffs
arm group label: E-cigarette without ethanol, 10 puffs
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Breland, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ethanol
sharing ipd: No
provided document: 