<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/NCT03306173</url>
  </required_header>
  <id_info>
    <org_study_id>CigVent Proj-003</org_study_id>
    <secondary_id>1P01CA217806</secondary_id>
    <nct_id>NCT03306173</nct_id>
  </id_info>
  <brief_title>COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM</brief_title>
  <official_title>COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Polytechnic Institute and State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</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>
      Early attempts by the tobacco industry to develop &quot;safer&quot; cigarettes led to the widespread&#xD;
      introduction of ventilation holes in cigarette filters; however, this design feature may&#xD;
      instead increase smoking-related harm and make cigarettes more palatable. The overall goal of&#xD;
      this project is to model regulatory restrictions banning cigarette filter ventilation and&#xD;
      determine their effects on consumption of both cigarettes and a wide range of alternative&#xD;
      tobacco products. Testing potential regulatory actions under controlled conditions will&#xD;
      facilitate evidence-based policies that have a net benefit to health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of the experiment will be approximately 3 months. Participants will begin with&#xD;
      an initial one week (approximately) exposure period to both unventilated and ventilated&#xD;
      cigarettes as well as alternative nicotine products (e-cigarettes, snus, etc.) that will be&#xD;
      made available throughout the experiment. Participants will be given the opportunity to&#xD;
      sample both types of cigarettes and alternative nicotine products. In the following sessions,&#xD;
      participants will alternate between Electronic Tobacco Marketplace (ETM) sessions and free&#xD;
      exposure periods to their assigned cigarette, with weekly assessments throughout to track&#xD;
      changes in smoking behavior and cigarette valuation. In total, participants will complete 10&#xD;
      experimental sessions (see Appendix B for experimental timeline figure). For the sake of&#xD;
      clarity, session types are separated below. The consent and initial sessions may take place&#xD;
      in the same or separate sessions.&#xD;
&#xD;
      At the beginning of the experiment, participants will be assigned to one of two groups:&#xD;
      ventilated or unventilated. Group assignment will determine what cigarettes will be given to&#xD;
      the participant after sessions in which they do not actually purchase their cigarettes of&#xD;
      choice. Additionally, participants that typically smoke menthol cigarettes will be given a&#xD;
      menthol version of their assigned cigarette. Cigarettes will be similar in design and will be&#xD;
      labeled as Typa A or Type B.&#xD;
&#xD;
      At the initial session and throughout the study, urine samples may be collected and stored&#xD;
      for testing (for tobacco use and pregnancy) and breath samples for carbon monoxide and&#xD;
      alcohol. Self-report may be used in place of urine analyses on a case-by-case bases. Urine&#xD;
      sample analyses for tobacco use may only take place at the VTCRI site.&#xD;
&#xD;
      Initial Assessment Session and Sampling (Session 1). First, participants will complete the&#xD;
      consenting process. The first session will be an assessment session to collect information&#xD;
      from participants on patterns and degree of tobacco and other substance use, perceptions of&#xD;
      all cigarette types available in the ETM, as well as the results of behavioral and cognitive&#xD;
      tasks that we think may inform or complement the results from the main study (see Appendix A&#xD;
      for a complete list and descriptions).&#xD;
&#xD;
      Participants will also complete the initial sampling period following the initial sampling&#xD;
      session. The goal of this period is to familiarize the participants with their randomly&#xD;
      assigned cigarette as well as alternative nicotine products. After their assessment session,&#xD;
      participants will be given a 7-day supply of ventilated and unventilated (3.5 days of&#xD;
      venitlated and 3.5 days of unventialted) cigarettes and asked to use these cigarettes. The&#xD;
      actual number of cigarettes delivered to each participant will be determined by multiplying&#xD;
      their reported cigarettes smoked per day by 7. Therefore, the average minimum number of&#xD;
      cigarettes that will be delivered is approximately 70 (10 cigarettes per day minimum to&#xD;
      qualify to participate). They will be also be given a sample of the alternative nicotine&#xD;
      products that will be made available during the Real-ETM sessions. Participants will be asked&#xD;
      to report their favorite flavor of each product to sample. If the participant is naïve to the&#xD;
      alternative nicotine product, they will be asked to estimate which product flavor they would&#xD;
      prefer. To verify usage during this and all subsequent usage period (see below), participants&#xD;
      will be asked to return spent cigarette filters in resealable bags we provide. However, while&#xD;
      participants will be asked to smoke the cigarettes they are given and to not use any other&#xD;
      cigarettes, they will only be asked to try the alternative nicotine products during the&#xD;
      sampling period, they do not have to finish them. A subset of these spent filters will be&#xD;
      randomly chosen and analyzed to permit correlation of mouth-level exposure to smoke&#xD;
      constituents with differences in ETM purchasing behavior between ventilated and unventilated&#xD;
      cigarettes. During this sampling period, participants will go about their daily lives,&#xD;
      allowing them to sample these cigarettes in the social environment in which they typically&#xD;
      operate. This &quot;real-world&quot; sampling period will serve to increase the generalizability of the&#xD;
      results obtained in the ETM sessions. This duration of exposure was chosen to give&#xD;
      participants time to begin to familiarize themselves with their assigned cigarettes. This&#xD;
      will enable them to make informed purchasing decisions during the upcoming sessions.&#xD;
&#xD;
      Real Experimental Tobacco Marketplace Sessions (Sessions 2,6, and 10).&#xD;
&#xD;
      Following the initial sampling period, participants will complete a purchasing session in our&#xD;
      realistic tobacco product marketplace. Participants will be seated in front of a computer to&#xD;
      access an online marketplace with an interface similar to many online merchants. This will&#xD;
      allow participants to browse through the products and add as many as they desire to the&#xD;
      virtual shopping cart. Each product will have the price clearly displayed along with an&#xD;
      image. Each ETM session will contain five pricing scenarios, in which we:&#xD;
&#xD;
      i. manipulate the price of participants' assigned cigarettes to assess demand in a context&#xD;
      with no other products available; ii. manipulate the price of participants' non-assigned&#xD;
      cigarettes to assess demand in a context with no other products available; iii. manipulate&#xD;
      the price of both assigned and non-assigned cigarettes in unison to assess simple preference&#xD;
      between the two; iv. manipulate the price of participants' assigned cigarettes while the&#xD;
      price of non-assigned cigarettes remains constant to assess the degree to which assigned&#xD;
      cigarettes substitute for non-assigned cigarettes;&#xD;
&#xD;
      a. In this task, alternative nicotine products (e.g., e-cigarettes, chew, etc.) may also be&#xD;
      available for purchase at a constant price.&#xD;
&#xD;
      v. manipulate the price of participants' non-assigned cigarette while the price of assigned&#xD;
      cigarettes remains constant to assess the degree to which non-assigned cigarettes substitute&#xD;
      for assigned cigarettes.&#xD;
&#xD;
      a. In this task, alternative nicotine products (e.g., e-cigarettes, chew, etc.) may also be&#xD;
      available for purchase at a constant price.&#xD;
&#xD;
      In each of these scenarios, the price-manipulated cigarettes will be available across a range&#xD;
      of prices (e.g., $0.12, $0.25, $0.50, $1.00, $2.00, and $4.00). Price-constant cigarettes&#xD;
      will be set to the median cigarette price in the community. Participants will use an&#xD;
      experimentally provided income (proportional to their real-world tobacco consumption) to&#xD;
      purchase from the ETM. At each price, participants will be asked to make seven days of&#xD;
      tobacco-product purchases from the ETM. After all 5 scenarios are complete for their assigned&#xD;
      cigarette, participants will receive the products they purchased from one randomly selected&#xD;
      price. Participants will be well informed of these procedures prior to purchasing. For those&#xD;
      seven days after marketplace sessions, participants will be asked to only use those products&#xD;
      they have purchased from the tobacco marketplace, and to not purchase any outside tobacco&#xD;
      products, to not sell or give away any of their purchases, and to not ask anybody else to&#xD;
      purchase products for them. We will strongly encourage participants to follow these&#xD;
      procedures, and to report any deviations from these procedures, which we will incorporate&#xD;
      into our statistical analyses. If the participant does not spend their entire income, they&#xD;
      will be allowed to keep the remainder. In this way, participants will be spending real money&#xD;
      and incurring a financial cost for their purchases, leading to more realistic product&#xD;
      selections. Following the seven days of using cigarettes obtained from the ETM, participants&#xD;
      will again visit the lab to return any unused products and report the use of experimenter&#xD;
      provided and non-experimenter provided tobacco products.&#xD;
&#xD;
      Extended Cigarette Exposure and Experimental Tobacco Marketplace Testing (Sessions 3, 4, 5,&#xD;
      7, 8, and 9).&#xD;
&#xD;
      Following the first session in the ETM and its associated period of tobacco product use,&#xD;
      participants will begin periods of freely provided exposure to their assigned cigarette&#xD;
      (ventilated or unventilated), alternating with two additional sessions in the ETM at regular&#xD;
      intervals. The purpose of this additional exposure between discrete ETM assessments is so&#xD;
      that we may examine the effects of sustained exposure to participants' assigned cigarettes at&#xD;
      regular intervals. During the extended-exposure periods, participants will visit the lab&#xD;
      every 7 days. At each of these sessions during extended-exposure periods, they will return&#xD;
      any unused cigarettes, report the use of experimenter provided and non-experimenter provided&#xD;
      tobacco products, receive cigarettes for the upcoming 7 days, and complete many of the&#xD;
      assessments they completed at their initial assessment session.&#xD;
&#xD;
      Following sessions 5 and 9 (the sessions immediately before the Real ETM sessions)&#xD;
      participants will be given 6 days of their assigned cigarettes and 1 day of the unassigned&#xD;
      cigarettes in order to expose the participant to the unassigned cigarettes before the Real&#xD;
      ETM session.&#xD;
&#xD;
      An abbreviated set of assessments will be collected on a weekly basis throughout the&#xD;
      experiment (Appendix A) in addition to any additional scheduled session (e.g., Real ETM).&#xD;
      These assessments will focus on measuring tobacco product use and measures of dependence and&#xD;
      withdrawal, including a Timeline Follow-Back for the period since the last session, as well&#xD;
      as product perceptions. We will also include a purely hypothetical version of the ETM (on&#xD;
      non-real ETM sessions), in which participants do not receive products purchased to use&#xD;
      outside the laboratory. Because these hypothetical ETM assessments can be repeated with&#xD;
      greater frequency and without interrupting periods of continuous exposure to assigned&#xD;
      cigarettes, data from hypothetical assessments will be used to inform determinations of the&#xD;
      effects of time on valuation of ventilated and unventilated cigarettes in more detail than&#xD;
      primary ETM assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2018</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be assigned to either use a ventilated or unventilated cigarette.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be randomly assigned to either ventilated or unventilated cigarettes and will not be informed of their group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Electronic Tobacco Marketplace</measure>
    <time_frame>Purchasing behavior will be collected weekly, up to 10 weeks.</time_frame>
    <description>The Electronic Tobacco Marketplace (ETM) measures participant purchasing of different nicotine products. Participants will be restricted to a budget based on how much they typically spend on tobacco products in a week. They will be allowed to purchase ventilated or unventilated cigarettes at a variety of prices. Alternative nicotine products will also be made available. For the three real-ETM sessions, participants will randomly draw to select an ETM trial and will be given the products purchased in that trial. ETMs with hypothetical purchasing will be used on the other sessions. The purpose of this task is the measure at what price does the unassigned cigarette function as a substitute for the assigned cigarette.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Ventilated cigarettes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this ARM will be assigned to ~25% filter ventilation commercially available cigarettes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unventilated cigarettes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this ARM will be assigned to ~0% filter ventilation commercially available cigarettes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Commercially available cigarette</intervention_name>
    <description>Commercially available cigarette with either ~0% or ~25% filter ventilation. Menthol flavor will be available in both types.</description>
    <arm_group_label>Unventilated cigarettes</arm_group_label>
    <arm_group_label>Ventilated cigarettes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current cigarette smoker&#xD;
&#xD;
          -  Stable mental and physical health&#xD;
&#xD;
          -  Does not take medications that interfere with nicotine metabolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Immediate future plans to quit smoking&#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>Warren K Bickel, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fralin Biomedical Research Institute at VTC</affiliation>
  </overall_official>
  <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>October 2021</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results from research conducted under this project will be disseminated in several ways. Findings will be presented at national conferences for groups such as the Society for Research on Nicotine and Tobacco (SRNT) and the College on Problems of Drug Dependence (CPDD). Manuscripts will be written and submitted for publication in a timely manner in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines.</ipd_description>
    <ipd_time_frame>Data will be made available upon request after dissemination of results.</ipd_time_frame>
    <ipd_access_criteria>Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.</ipd_access_criteria>
  </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>July 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03306173/Prot_002.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>October 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03306173/SAP_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/NCT03306173
org study id: CigVent Proj-003
secondary id: 1P01CA217806
nct id: NCT03306173
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Early attempts by the tobacco industry to develop "safer" cigarettes led to the widespread
      introduction of ventilation holes in cigarette filters; however, this design feature may
      instead increase smoking-related harm and make cigarettes more palatable. The overall goal of
      this project is to model regulatory restrictions banning cigarette filter ventilation and
      determine their effects on consumption of both cigarettes and a wide range of alternative
      tobacco products. Testing potential regulatory actions under controlled conditions will
      facilitate evidence-based policies that have a net benefit to health.
The duration of the experiment will be approximately 3 months. Participants will begin with
      an initial one week (approximately) exposure period to both unventilated and ventilated
      cigarettes as well as alternative nicotine products (e-cigarettes, snus, etc.) that will be
      made available throughout the experiment. Participants will be given the opportunity to
      sample both types of cigarettes and alternative nicotine products. In the following sessions,
      participants will alternate between Electronic Tobacco Marketplace (ETM) sessions and free
      exposure periods to their assigned cigarette, with weekly assessments throughout to track
      changes in smoking behavior and cigarette valuation. In total, participants will complete 10
      experimental sessions (see Appendix B for experimental timeline figure). For the sake of
      clarity, session types are separated below. The consent and initial sessions may take place
      in the same or separate sessions.

      At the beginning of the experiment, participants will be assigned to one of two groups:
      ventilated or unventilated. Group assignment will determine what cigarettes will be given to
      the participant after sessions in which they do not actually purchase their cigarettes of
      choice. Additionally, participants that typically smoke menthol cigarettes will be given a
      menthol version of their assigned cigarette. Cigarettes will be similar in design and will be
      labeled as Typa A or Type B.

      At the initial session and throughout the study, urine samples may be collected and stored
      for testing (for tobacco use and pregnancy) and breath samples for carbon monoxide and
      alcohol. Self-report may be used in place of urine analyses on a case-by-case bases. Urine
      sample analyses for tobacco use may only take place at the VTCRI site.

      Initial Assessment Session and Sampling (Session 1). First, participants will complete the
      consenting process. The first session will be an assessment session to collect information
      from participants on patterns and degree of tobacco and other substance use, perceptions of
      all cigarette types available in the ETM, as well as the results of behavioral and cognitive
      tasks that we think may inform or complement the results from the main study (see Appendix A
      for a complete list and descriptions).

      Participants will also complete the initial sampling period following the initial sampling
      session. The goal of this period is to familiarize the participants with their randomly
      assigned cigarette as well as alternative nicotine products. After their assessment session,
      participants will be given a 7-day supply of ventilated and unventilated (3.5 days of
      venitlated and 3.5 days of unventialted) cigarettes and asked to use these cigarettes. The
      actual number of cigarettes delivered to each participant will be determined by multiplying
      their reported cigarettes smoked per day by 7. Therefore, the average minimum number of
      cigarettes that will be delivered is approximately 70 (10 cigarettes per day minimum to
      qualify to participate). They will be also be given a sample of the alternative nicotine
      products that will be made available during the Real-ETM sessions. Participants will be asked
      to report their favorite flavor of each product to sample. If the participant is naïve to the
      alternative nicotine product, they will be asked to estimate which product flavor they would
      prefer. To verify usage during this and all subsequent usage period (see below), participants
      will be asked to return spent cigarette filters in resealable bags we provide. However, while
      participants will be asked to smoke the cigarettes they are given and to not use any other
      cigarettes, they will only be asked to try the alternative nicotine products during the
      sampling period, they do not have to finish them. A subset of these spent filters will be
      randomly chosen and analyzed to permit correlation of mouth-level exposure to smoke
      constituents with differences in ETM purchasing behavior between ventilated and unventilated
      cigarettes. During this sampling period, participants will go about their daily lives,
      allowing them to sample these cigarettes in the social environment in which they typically
      operate. This "real-world" sampling period will serve to increase the generalizability of the
      results obtained in the ETM sessions. This duration of exposure was chosen to give
      participants time to begin to familiarize themselves with their assigned cigarettes. This
      will enable them to make informed purchasing decisions during the upcoming sessions.

      Real Experimental Tobacco Marketplace Sessions (Sessions 2,6, and 10).

      Following the initial sampling period, participants will complete a purchasing session in our
      realistic tobacco product marketplace. Participants will be seated in front of a computer to
      access an online marketplace with an interface similar to many online merchants. This will
      allow participants to browse through the products and add as many as they desire to the
      virtual shopping cart. Each product will have the price clearly displayed along with an
      image. Each ETM session will contain five pricing scenarios, in which we:

      i. manipulate the price of participants' assigned cigarettes to assess demand in a context
      with no other products available; ii. manipulate the price of participants' non-assigned
      cigarettes to assess demand in a context with no other products available; iii. manipulate
      the price of both assigned and non-assigned cigarettes in unison to assess simple preference
      between the two; iv. manipulate the price of participants' assigned cigarettes while the
      price of non-assigned cigarettes remains constant to assess the degree to which assigned
      cigarettes substitute for non-assigned cigarettes;

      a. In this task, alternative nicotine products (e.g., e-cigarettes, chew, etc.) may also be
      available for purchase at a constant price.

      v. manipulate the price of participants' non-assigned cigarette while the price of assigned
      cigarettes remains constant to assess the degree to which non-assigned cigarettes substitute
      for assigned cigarettes.

      a. In this task, alternative nicotine products (e.g., e-cigarettes, chew, etc.) may also be
      available for purchase at a constant price.

      In each of these scenarios, the price-manipulated cigarettes will be available across a range
      of prices (e.g., $0.12, $0.25, $0.50, $1.00, $2.00, and $4.00). Price-constant cigarettes
      will be set to the median cigarette price in the community. Participants will use an
      experimentally provided income (proportional to their real-world tobacco consumption) to
      purchase from the ETM. At each price, participants will be asked to make seven days of
      tobacco-product purchases from the ETM. After all 5 scenarios are complete for their assigned
      cigarette, participants will receive the products they purchased from one randomly selected
      price. Participants will be well informed of these procedures prior to purchasing. For those
      seven days after marketplace sessions, participants will be asked to only use those products
      they have purchased from the tobacco marketplace, and to not purchase any outside tobacco
      products, to not sell or give away any of their purchases, and to not ask anybody else to
      purchase products for them. We will strongly encourage participants to follow these
      procedures, and to report any deviations from these procedures, which we will incorporate
      into our statistical analyses. If the participant does not spend their entire income, they
      will be allowed to keep the remainder. In this way, participants will be spending real money
      and incurring a financial cost for their purchases, leading to more realistic product
      selections. Following the seven days of using cigarettes obtained from the ETM, participants
      will again visit the lab to return any unused products and report the use of experimenter
      provided and non-experimenter provided tobacco products.

      Extended Cigarette Exposure and Experimental Tobacco Marketplace Testing (Sessions 3, 4, 5,
      7, 8, and 9).

      Following the first session in the ETM and its associated period of tobacco product use,
      participants will begin periods of freely provided exposure to their assigned cigarette
      (ventilated or unventilated), alternating with two additional sessions in the ETM at regular
      intervals. The purpose of this additional exposure between discrete ETM assessments is so
      that we may examine the effects of sustained exposure to participants' assigned cigarettes at
      regular intervals. During the extended-exposure periods, participants will visit the lab
      every 7 days. At each of these sessions during extended-exposure periods, they will return
      any unused cigarettes, report the use of experimenter provided and non-experimenter provided
      tobacco products, receive cigarettes for the upcoming 7 days, and complete many of the
      assessments they completed at their initial assessment session.

      Following sessions 5 and 9 (the sessions immediately before the Real ETM sessions)
      participants will be given 6 days of their assigned cigarettes and 1 day of the unassigned
      cigarettes in order to expose the participant to the unassigned cigarettes before the Real
      ETM session.

      An abbreviated set of assessments will be collected on a weekly basis throughout the
      experiment (Appendix A) in addition to any additional scheduled session (e.g., Real ETM).
      These assessments will focus on measuring tobacco product use and measures of dependence and
      withdrawal, including a Timeline Follow-Back for the period since the last session, as well
      as product perceptions. We will also include a purely hypothetical version of the ETM (on
      non-real ETM sessions), in which participants do not receive products purchased to use
      outside the laboratory. Because these hypothetical ETM assessments can be repeated with
      greater frequency and without interrupting periods of continuous exposure to assigned
      cigarettes, data from hypothetical assessments will be used to inform determinations of the
      effects of time on valuation of ventilated and unventilated cigarettes in more detail than
      primary ETM assessments.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned to either use a ventilated or unventilated cigarette.
primary purpose: Other
masking: Single (Participant)
masking description: Participants will be randomly assigned to either ventilated or unventilated cigarettes and will not be informed of their group assignment.
measure: Electronic Tobacco Marketplace
time frame: Purchasing behavior will be collected weekly, up to 10 weeks.
description: The Electronic Tobacco Marketplace (ETM) measures participant purchasing of different nicotine products. Participants will be restricted to a budget based on how much they typically spend on tobacco products in a week. They will be allowed to purchase ventilated or unventilated cigarettes at a variety of prices. Alternative nicotine products will also be made available. For the three real-ETM sessions, participants will randomly draw to select an ETM trial and will be given the products purchased in that trial. ETMs with hypothetical purchasing will be used on the other sessions. The purpose of this task is the measure at what price does the unassigned cigarette function as a substitute for the assigned cigarette.
arm group label: Ventilated cigarettes
arm group type: Experimental
description: Participants in this ARM will be assigned to ~25% filter ventilation commercially available cigarettes.
arm group label: Unventilated cigarettes
arm group type: Experimental
description: Participants in this ARM will be assigned to ~0% filter ventilation commercially available cigarettes.
intervention type: Other
intervention name: Commercially available cigarette
description: Commercially available cigarette with either ~0% or ~25% filter ventilation. Menthol flavor will be available in both types.
arm group label: Unventilated cigarettes
arm group label: Ventilated cigarettes
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Warren K Bickel, PHD
role: Principal Investigator
affiliation: Fralin Biomedical Research Institute at VTC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Yes
ipd description: Results from research conducted under this project will be disseminated in several ways. Findings will be presented at national conferences for groups such as the Society for Research on Nicotine and Tobacco (SRNT) and the College on Problems of Drug Dependence (CPDD). Manuscripts will be written and submitted for publication in a timely manner in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines.
ipd time frame: Data will be made available upon request after dissemination of results.
ipd access criteria: Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.
provided document: 
provided document: 