Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      Participants will be given the opportunity to purchase ventilated, unventilated, and
      alternative nicotine products at different prices using an account balance based on their
      typical, daily nicotine product purchasing. Additionally, account balances will differ across
      trials.
    

Detailed description: 
      The 2014 Surgeon General's Report on the Health Consequences of Smoking concludes that
      changes in the physical design of cigarettes have caused an increased risk of developing lung
      cancer. One prominent cigarette design feature is filter ventilation, which has become
      increasingly common since the 1960s. Now, ventilated cigarettes now dominate the tobacco
      market. Filter ventilation alters cigarette burn rate and smoking topography. Ventilated
      cigarettes increase how much smoke is inhaled and therefore exposure to carcinogens.
      Moreover, because ventilated cigarettes most frequently feature low nicotine yield, smokers
      of highly ventilated cigarettes also smoke more cigarettes per day to compensate for reduced
      nicotine; this, in turn, further increases exposure to mutagens and carcinogens in tobacco
      smoke.

      The Food and Drug Administration has the authority to ban filter ventilation. However, we
      currently don't know what such a ban would do to consumption of unventilated cigarettes--that
      is, whether smokers would switch to unventilated cigarettes and demonstrate similar levels of
      consumption, or whether smokers would reduce cigarette consumption or quit entirely. We also
      do not know if such a ban would result in the substitution of other nicotine products (e.g.,
      electronic cigarettes, cigarillos, etc.). One way of understanding the effects of ventilation
      bans on tobacco consumption is to investigate unventilated cigarettes as an inferior good. An
      inferior good is an inferior substitute for a preferred product. This can be established by
      manipulating the account balance of a cigarette smoker. A good is determined inferior if its
      consumption decreases as the account balance for tobacco products increases. Thus, in the
      present studies, we will examine the behavioral economic demand for unventilated cigarettes
      in participants who normally smoke highly ventilated cigarette varieties (i.e., "ultra light"
      and "light" cigarettes). Using an account balance we provide, participants will purchase
      ventilated and/or unventilated cigarettes in three separate sessions across a range of prices
      (e.g., $0.12, $0.25, $0.50. $1.00, $2.00 per cigarette). For some participants, some
      participants may also have access to alternative nicotine products such as cigarillos, gum,
      or lozenges. Participants will be asked to make these purchases under six different account
      balance conditions. From each session, purchases from one price will be randomly selected and
      participants will take home all cigarettes purchased at that price. Participants will later
      return to the lab to return any unused cigarettes and receive reimbursement for these unused
      products.

      The study will take place over approximately four experimental sessions (one consent session,
      two purchase sessions, and one follow-up session) at the VTCRI's Addiction Recovery Research
      Center or the Virginia Tech Corporate Research Center. The initial consent session will last
      approximately two hours; the two purchase sessions and the final follow-up session in which
      subjects report consumption of, and/or return for reimbursement, their purchased cigarettes
      will last approximately 30 minutes to 1 hour each. Participants may also complete a brief
      (5-10 minutes) phone interview daily throughout participation, during which they will be
      asked to provide the number of study and non-study products they have used the previous
      day(s). They will be asked about their tobacco consumption at the laboratory sessions for
      days in which the data from the phone screen was not collected. Participants will also be
      asked to provide a breath sample for recent alcohol use at each session.

      During the consent session, participants will provide informed consent (see section 4, above,
      for details), provide a baseline CO breath sample, and may also be asked to leave a urine
      sample. This sample may be tested for recent drug use and pregnancy, when applicable. During
      the consent sessions, and throughout the study, participants will also be asked to complete
      one or more of the following: the AUDIT questionnaire, questionnaires about cigarette use,
      craving withdrawal, delay-discounting tasks, cigarette demand, and ETM tasks.

      Participants will then be given samples of the ETM cigarettes and/or alternative nicotine
      products (if that participant is assigned to ETM conditions that have more than cigarettes).
      Commercially available cigarettes will be used. Specifically, Marlboro Black 100's (~1.5%
      ventilation) and Marlboro Gold 100's (~28% ventilation). For participants that typically
      smoke menthol cigarettes, they will be given menthol versions of the Marlboro cigarettes.
      Importantly, the cigarettes will be labeled as "Cigarette A" or "Cigarette B." While both
      cigarettes are labeled with the Marlboro logo, they are not explicitly labeled as ventilated
      or unventilated. If participants are assigned to conditions where they will also purchase
      alternative nicotine products, they may be given samples of those products as well. Popular
      flavors of the alternative nicotine products will be made available. Participants will then
      take these samples home to use over approximately the next three days. The end of this
      sampling period will coincide with the first purchase session, at which time participants
      will return any unused samples.

      Participants will then begin reporting to the laboratory approximately once every 2 days at a
      consistent time of day. Breath samples will be collected at each visit to measure CO.
      Participants will be informed that during the study they will be expected to only use
      products that we provide to them, but that the use of other products will not disqualify them
      from the study if they are accurately reported to us. This approach is intended to discourage
      the use of products that are not provided within the study while encouraging accurate
      self-reporting of such use. We will use a timeline follow-back procedure, or structured
      interview of recent product use to assess the use of other products outside of the
      laboratory.

      At each of two purchase sessions, participants will "purchase" two days' worth of either the
      Marlboro Blacks or Golds in one session. Here, they will report the number of cigarettes they
      would like to purchase across increasing prices (e.g., $0.12, $0.25, $0.50, $1.00, $2.00 per
      cigarette). In one session, the price of both ventilated and unventilated cigarettes will
      increase in tandem across trials. In the other session, only the price of ventilated
      cigarettes will increase across trials. They will complete this task 6 times at each session.
      Once with the account balance that reflects what they typically spend on tobacco products
      (100%). The full range of account balances will be 140%, 120%, 100%, 80%, 60%, and 40%. At
      the end of each session, one price from one of the six times they complete the task will be
      drawn randomly and the participant will take home all cigarettes purchased at this price.
      Participants may also complete hypothetical purchase tasks. For some participants,
      alternative nicotine products such as cigarillos, gum, or lozenges may be available as well
      in both the real and hypothetical purchase tasks.

      In each of the purchase sessions, participants will be able to purchase as many cigarettes
      (or alternative nicotine products) as their account balance allows, with the total price of
      the products purchased deducted from their account balance. Participants will be informed
      that the price of any unused products that are returned to the laboratory at their next visit
      will be refunded to their account. Thus, the number of cigarettes used outside of the
      laboratory will be calculated from the amount that is provided minus the amount that is
      returned. Before and after each session, participants may be asked to complete product
      evaluation surveys to measure changes over the course of the study. Participants will also be
      asked to return used cigarette filters (and cigarillo butts, depending on their availability)
      following each purchase session and the sampling period in order to qualify for the next
      session so that we may detect tampering or alteration of our method of ventilation blocking.

      Participants will also complete a series of computerized and/or paper assessments (see
      attached task files for examples) during the consent session, purchase, and/or follow-up
      sessions. Likewise, in all sessions, participants may also be asked to leave a urine sample.
      This sample may be tested for recent drug use and pregnancy, when applicable.

      To allow for payments that are both convenient and rapidly available, we may pay participants
      with reloadable prepaid cards through Greenphire ClinCard (www.greenphire.com), an
      FDIC-insured payment provider that specializes in clinical trial stipend payments that comply
      with IRB privacy regulations and considerations. At the beginning of the study, the
      participant will receive a prepaid MasterCard debit card that can be used anywhere that
      accepts MasterCard. As payments are earned in the course of the study, additional funds will
      be added to the account for that participant. Funds are immediately available when added and
      participants can check their balance as desired. This system will allow frequent, immediately
      available payments. Payments may also be made via check, however remote debit card payments
      and checks will be used most often.
    

Intervention name(s): Experimental Tobacco Marketplace
Intervention type(s): Behavioral
Intervention description(s): See arm group description.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Unventilated Cigarettes; Experimental Tobacco Marketplace; Demand; Delay Discounting