xml: <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/NCT05971823</url>
    </required_header>
    <id_info>
      <org_study_id>HM20025464</org_study_id>
      <secondary_id>2U54DA036105</secondary_id>
      <nct_id>NCT05971823</nct_id>
    </id_info>
    <brief_title>Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)</brief_title>
    <official_title>Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine if abuse liability indices will be impacted by&#xD;
        varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux)&#xD;
        among current combustible cigarette users.&#xD;
  &#xD;
        The investigators will compare abuse liability indices between three FDA-authorized ECIG&#xD;
        products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes.&#xD;
        The investigators will also test the influence of ECIG flavor availability (tobacco vs.&#xD;
        menthol) within three ECIG product classes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Participants will complete 4, within-subject, laboratory sessions that differ by the product used: 1) own brand cigarette, 2) NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3) NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco). The first condition for all participants will be their own brand cigarette. The subsequent three sessions will be assigned using a Latin-square following enrollment, and within each session participants will sample and evaluate two flavors of each session's product (session flavor order is incorporated into the Latin-square condition order assignment).</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be blinded to device nicotine concentration and flavor used during ECIG sessions. No blinding will occur for the own brand condition.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Breakpoint of Drug Purchase Task (DPT)</measure>
      <time_frame>Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session</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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Elasticity of Drug Purchase Task (DPT)</measure>
      <time_frame>Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session</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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Omax of Drug Purchase Task (DPT)</measure>
      <time_frame>A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm.</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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pmax of Drug Purchase Task (DPT)</measure>
      <time_frame>Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session</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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intensity of Drug Purchase Task (DPT)</measure>
      <time_frame>Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session</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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cross-price elasticity of the Cross Product-DPT</measure>
      <time_frame>Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session</time_frame>
      <description>The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Subjective measures of nicotine withdrawal</measure>
      <time_frame>Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session</time_frame>
      <description>Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS), higher numbers indicate more nicotine dependence.</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective measures of nicotine side effects</measure>
      <time_frame>Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session</time_frame>
      <description>Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS), higher scores indicate more intense nicotine side effects.</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective measures of product effects</measure>
      <time_frame>Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session</time_frame>
      <description>Product effects will be measured using Direct Effects of Tobacco VAS Scale, higher scores indicate more intense product effects.</description>
    </other_outcome>
    <other_outcome>
      <measure>General Labeled Magnitude Scale</measure>
      <time_frame>Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session</time_frame>
      <description>Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms), higher scores indicate stronger perceptions of nicotine effects.</description>
    </other_outcome>
    <other_outcome>
      <measure>Labeled Hedonic Scale</measure>
      <time_frame>Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session</time_frame>
      <description>Labeled Hedonic Scale measures nicotine abstinence symptoms, higher scores indicate higher abstinence symptoms</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Heart Rate</measure>
      <time_frame>Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.</time_frame>
      <description>Heart rate (measured in bpm)</description>
    </other_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Electronic Cigarette Use</condition>
    <arm_group>
      <arm_group_label>Own Brand Cigarette</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Ace 2.4% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Ace 5.0% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Daily 6.0% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Tobacco product administration and assessment</intervention_name>
      <description>Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.</description>
      <arm_group_label>NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor</arm_group_label>
      <arm_group_label>NJOY Ace 2.4% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_label>NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor</arm_group_label>
      <arm_group_label>NJOY Ace 5.0% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_label>NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor</arm_group_label>
      <arm_group_label>NJOY Daily 6.0% nicotine ECIG - Menthol flavor</arm_group_label>
      <arm_group_label>Own Brand Cigarette</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  healthy (determined by self-report)&#xD;
  &#xD;
            -  at least 18 years old&#xD;
  &#xD;
            -  willing to provide informed consent&#xD;
  &#xD;
            -  able to attend the lab and use designated products according to study protocol&#xD;
  &#xD;
            -  smoke cigarettes at least 3 days per week and on those days at least 1 cigarette&#xD;
               smoked per day&#xD;
  &#xD;
            -  positive urine cotinine test&#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&#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>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Caroline O Cobb, 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>
    <overall_contact>
      <last_name>Caroline O Cobb, PhD</last_name>
      <phone>804-827-3562</phone>
      <email>cobbco@vcu.edu</email>
    </overall_contact>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Caroline Cobb, PhD</last_name>
        <phone>804-827-3562</phone>
        <email>cstp@vcu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Electronic Cigarette</keyword>
    <keyword>Nicotine Flux</keyword>
    <keyword>Tobacco Use</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971823
  org study id: HM20025464
  secondary id: 2U54DA036105
  nct id: NCT05971823
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to determine if abuse liability indices will be impacted by
        varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux)
        among current combustible cigarette users.
  
        The investigators will compare abuse liability indices between three FDA-authorized ECIG
        products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes.
        The investigators will also test the influence of ECIG flavor availability (tobacco vs.
        menthol) within three ECIG product classes.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: Participants will complete 4, within-subject, laboratory sessions that differ by the product used: 1) own brand cigarette, 2) NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3) NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco). The first condition for all participants will be their own brand cigarette. The subsequent three sessions will be assigned using a Latin-square following enrollment, and within each session participants will sample and evaluate two flavors of each session's product (session flavor order is incorporated into the Latin-square condition order assignment).
  primary purpose: Basic Science
  masking: Single (Participant)
  masking description: Participants will be blinded to device nicotine concentration and flavor used during ECIG sessions. No blinding will occur for the own brand condition.
  measure: Breakpoint of Drug Purchase Task (DPT)
  time frame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
  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.
  measure: Elasticity of Drug Purchase Task (DPT)
  time frame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
  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.
  measure: Omax of Drug Purchase Task (DPT)
  time frame: A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm.
  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.
  measure: Pmax of Drug Purchase Task (DPT)
  time frame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
  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.
  measure: Intensity of Drug Purchase Task (DPT)
  time frame: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
  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.
  measure: Cross-price elasticity of the Cross Product-DPT
  time frame: Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
  description: The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices.
  measure: Subjective measures of nicotine withdrawal
  time frame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
  description: Nicotine withdrawal will be measured using the Adapted Minnesota Nicotine Withdrawal Scale (MNWS), higher numbers indicate more nicotine dependence.
  measure: Subjective measures of nicotine side effects
  time frame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
  description: Nicotine side effects will be measured using the Direct Effects of Nicotine Scale (DENS), higher scores indicate more intense nicotine side effects.
  measure: Subjective measures of product effects
  time frame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
  description: Product effects will be measured using Direct Effects of Tobacco VAS Scale, higher scores indicate more intense product effects.
  measure: General Labeled Magnitude Scale
  time frame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
  description: Perceptions of electronic cigarette effects will be measured using the General Labeled Magnitude Scale (gLms), higher scores indicate stronger perceptions of nicotine effects.
  measure: Labeled Hedonic Scale
  time frame: Up to 55 minutes (session 1) and up to 120 minutes (sessions 2-4) into the session
  description: Labeled Hedonic Scale measures nicotine abstinence symptoms, higher scores indicate higher abstinence symptoms
  measure: Change in Heart Rate
  time frame: Recorded throughout each 1 hour and 10 minutes/2 hour and 15 minute study session using automated software every 10 seconds.
  description: Heart rate (measured in bpm)
  arm group label: Own Brand Cigarette
  arm group type: Active Comparator
  arm group label: NJOY Ace 2.4% nicotine ECIG - Menthol flavor
  arm group type: Experimental
  arm group label: NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor
  arm group type: Experimental
  arm group label: NJOY Ace 5.0% nicotine ECIG - Menthol flavor
  arm group type: Experimental
  arm group label: NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor
  arm group type: Experimental
  arm group label: NJOY Daily 6.0% nicotine ECIG - Menthol flavor
  arm group type: Experimental
  arm group label: NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor
  arm group type: Experimental
  intervention type: Other
  intervention name: Tobacco product administration and assessment
  description: Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.
  arm group label: NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor
  arm group label: NJOY Ace 2.4% nicotine ECIG - Menthol flavor
  arm group label: NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor
  arm group label: NJOY Ace 5.0% nicotine ECIG - Menthol flavor
  arm group label: NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor
  arm group label: NJOY Daily 6.0% nicotine ECIG - Menthol flavor
  arm group label: Own Brand Cigarette
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Caroline O Cobb, PhD
  role: Principal Investigator
  affiliation: Virginia Commonwealth University
  last name: Andrew Barnes, PhD
  role: Principal Investigator
  affiliation: Virginia Commonwealth University
  last name: Caroline O Cobb, PhD
  phone: 804-827-3562
  email: cobbco@vcu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes