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/NCT06001840</url>
    </required_header>
    <id_info>
      <org_study_id>5P01CA200512</org_study_id>
      <nct_id>NCT06001840</nct_id>
    </id_info>
    <brief_title>Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases</brief_title>
    <official_title>Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Polytechnic Institute and State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Virginia Polytechnic Institute and State 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 will investigate the effects of promotion factors and mitigation strategies on&#xD;
        legal and illegal tobacco purchases for different tobacco-user types.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the present study, we propose to examine some promotion factors and mitigation strategies&#xD;
        and how they impact tobacco product legal and illegal purchases. Specifically, we have&#xD;
        developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify&#xD;
        the number, type, and characteristics of tobacco users who would seek illegal tobacco&#xD;
        products and the conditions that would induce them to seek that option. The critical&#xD;
        questions we seek to answer are whether changes in product standards and availability will&#xD;
        engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive&#xD;
        combustible product users, and dual cigarette/NVP users). Understanding the user types and&#xD;
        the relevant conditions will inform greater tailoring of policy to diminish consumer interest&#xD;
        in an illegal market.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2024</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 examine two promotion policies. In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion spent in each marketplace (Legal and Illegal)</measure>
      <time_frame>1 day</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Cigarette Smoking</condition>
    <condition>Nicotine Vaping</condition>
    <arm_group>
      <arm_group_label>Experimental: Exclusive cigarette smokers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental: Dual cigarette/ nicotine vaping product users</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Promotion factors</intervention_name>
      <description>In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.</description>
      <arm_group_label>Experimental: Dual cigarette/ nicotine vaping product users</arm_group_label>
      <arm_group_label>Experimental: Exclusive cigarette smokers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mitigation strategies</intervention_name>
      <description>Health Communications. The first narrative describes a person unknown to the participant who purchases from the illegal market and experiences negative life outcomes (e.g., ill health from contaminants). The second narrative incorporates cognitive biases of social proof (i.e., portraying a choice as the opinion of the majority).&#xD;
  Availability of Nicotine Replacement Therapies (NRT): Transdermal NRT will be available in the LETM at two different prices. In one condition, transdermal NRT will be available at a 50% subsidy in the form of coupons. In the other condition, a five-day supply of NRT will be available for free.&#xD;
  Penalties: Penalties will be presented in different fine magnitudes along with a description of the consequences of illegal purchases (i.e., a criminal record).</description>
      <arm_group_label>Experimental: Dual cigarette/ nicotine vaping product users</arm_group_label>
      <arm_group_label>Experimental: Exclusive cigarette smokers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide informed consent&#xD;
  &#xD;
            -  Be at least 21 years of age or older&#xD;
  &#xD;
            -  Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)&#xD;
  &#xD;
            -  Stable tobacco use patterns for at least two months&#xD;
  &#xD;
          For exclusive cigarette smokers:&#xD;
  &#xD;
            -  Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times&#xD;
               in the last month).&#xD;
  &#xD;
            -  For dual cigarette/NVP users:&#xD;
  &#xD;
            -  Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use&#xD;
               of closed nicotine salt system)&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Have plans to move out of the area&#xD;
  &#xD;
            -  Have a serious or unstable physical or mental health condition&#xD;
  &#xD;
            -  Taking a tobacco cessation medication or medication that interferes with nicotine&#xD;
               metabolism, motivation or reinforcement&#xD;
  &#xD;
            -  Report concrete, immediate plans to alter/quit using their usual nicotine products at&#xD;
               the beginning of the study&#xD;
  &#xD;
            -  Being pregnant or lactating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daniel Cabral, Ph.D.</last_name>
      <phone>540-526-2136</phone>
      <email>danielcabral@vtc.vt.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Warren Bickel, Ph.D.</last_name>
      <email>wbickel@vtc.vt.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fralin Biomedical Research Institute at VTC</name>
        <address>
          <city>Roanoke</city>
          <state>Virginia</state>
          <zip>24016</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study team will share de-identified data upon request.</ipd_description>
    </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/NCT06001840
  org study id: 5P01CA200512
  nct id: NCT06001840
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will investigate the effects of promotion factors and mitigation strategies on
        legal and illegal tobacco purchases for different tobacco-user types.
  In the present study, we propose to examine some promotion factors and mitigation strategies
        and how they impact tobacco product legal and illegal purchases. Specifically, we have
        developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify
        the number, type, and characteristics of tobacco users who would seek illegal tobacco
        products and the conditions that would induce them to seek that option. The critical
        questions we seek to answer are whether changes in product standards and availability will
        engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive
        combustible product users, and dual cigarette/NVP users). Understanding the user types and
        the relevant conditions will inform greater tailoring of policy to diminish consumer interest
        in an illegal market.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: We will examine two promotion policies. In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Proportion spent in each marketplace (Legal and Illegal)
  time frame: 1 day
  arm group label: Experimental: Exclusive cigarette smokers
  arm group type: Experimental
  description: Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
  arm group label: Experimental: Dual cigarette/ nicotine vaping product users
  arm group type: Experimental
  description: Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section
  intervention type: Behavioral
  intervention name: Promotion factors
  description: In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.
  arm group label: Experimental: Dual cigarette/ nicotine vaping product users
  arm group label: Experimental: Exclusive cigarette smokers
  intervention type: Behavioral
  intervention name: Mitigation strategies
  description: Health Communications. The first narrative describes a person unknown to the participant who purchases from the illegal market and experiences negative life outcomes (e.g., ill health from contaminants). The second narrative incorporates cognitive biases of social proof (i.e., portraying a choice as the opinion of the majority).
  Availability of Nicotine Replacement Therapies (NRT): Transdermal NRT will be available in the LETM at two different prices. In one condition, transdermal NRT will be available at a 50% subsidy in the form of coupons. In the other condition, a five-day supply of NRT will be available for free.
  Penalties: Penalties will be presented in different fine magnitudes along with a description of the consequences of illegal purchases (i.e., a criminal record).
  arm group label: Experimental: Dual cigarette/ nicotine vaping product users
  arm group label: Experimental: Exclusive cigarette smokers
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel Cabral, Ph.D.
  phone: 540-526-2136
  email: danielcabral@vtc.vt.edu
  last name: Warren Bickel, Ph.D.
  email: wbickel@vtc.vt.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: The study team will share de-identified data upon request.