COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Commercially available cigarette
Intervention type(s): Other
Intervention description(s): Commercially available cigarette with either ~0% or ~25% filter ventilation. Menthol flavor will be available in both types.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to either use a ventilated or unventilated cigarette.
Masking: Single (Participant)
Primary purpose: Other