Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7
Phase: NA
Conditions: Cigarette Smoking
Sponsor: Virginia Polytechnic Institute and State University

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InferiorGood-18-290 
 
Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7 
Study Protocol 
3/16/2018 
 
 
 
 

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Protocol 
Introduction 
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 no if such a ban would result in the substitution of other nicotine procucts (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.  
Participants 
Up to 160 smokers will participate in this study. To participate, smokers must:  
1) provide written informed consent,  
2) be 18-65 years of age,  
3) be an active smoker,  

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4) report smoking daily in the past month,  
5) have stable self-reported mental and physical health,  
6) be willing to try unventilated cigarettes or alternative nicotine products. 
7) report that their usual brand of cigarettes features >~20% filter ventilation (i.e., "ultra light" 
and "light" varieties). 
Individuals will be excluded from participating if they are trying or have immediate plans to quit 
smoking, are currently using prescription medication that might affect smoking or nicotine 
metabolism (e.g., varenicline, bupropion), have plans to move away from the area, or report 
regular use of electronic cigarettes, nicotine replacement therapy, or other alternative tobacco 
products (e.g., chewing tobacco). Females of childbearing age who report not having gone 
through menopause will be excluded from participating if they are pregnant (through urine 
screen at the time of consent) or lactating. Participants who meet DSM criteria for other 
substance dependence will be evaluated for eligibility on a case by case basis. 
Recruitment 
Participants will be recruited using a separate IRB protocol to screen cigarette smokers into a 
variety of smoking studies in our lab (see IRB #17-870), as well as study flyers. 
To the extent possible, we will attempt to minimize obstacles to participation. For example, 
travel barriers may be addressed by providing transportation or parking costs for participants, 
and scheduling barriers will be minimized by offering a flexible study visit schedule. 
Compensation may be provided for travel costs and time. We have a history of successful 
recruitment of cigarette smokers into research programs. All participants will enroll on a 
voluntary basis. 
Consenting Process 
Potential participants will be provided with the written consent form prior to visiting VTCRI or 
the Virginia Tech Corporate Research Center (VTCRC) (e.g., by email), if they wish. They will also 
be given additional time in a quiet room at VTCRI or VTCRC to read the form. VTCRI research 
staff will review each element of the written consent form with the potential participant. The 
potential participant will be given the opportunity to ask questions and will have as much time 
as they need to decide whether they would like to participate in the study. They will be 
encouraged to speak with whomever they wish before making this decision. Staff will reiterate 
that the potential participant can choose to decline participation in the study at that time or at 
any time thereafter without consequence. The potential participant and person obtaining 
consent will sign the consent form after the potential participant verbally states that s/he 
understands the conditions of the study, has no more questions, and chooses to participate. 
Procedures 

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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. 

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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.   
Risks and Benefits 

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     One risk of participation is embarrassment that may come from answering sensitive 
questions related to medical, psychiatric, and/or drug use history. Loss of confidentiality is 
another risk of participation. Additionally, because the present experiment allows and 
sometimes involves participants self-administering cigarettes or other alternative nicotine 
products, participants might experience adverse effects associated with the use of nicotine 
products (e.g., nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) or 
withdrawal from nicotine (e.g., anxiety, irritability, difficulty concentrating). However, the 
amount of nicotine consumed is not expected to be different from what participants normally 
consume. 
Data Protection 
     The linked code and identifying information document will be stored  in a locked cabinet 
separate from the coded data, accessible only by members of the research team who have 
completed VT Human Subjects Training. The electronic version (REDCap) requires a VTC-issued 
user name and password and access is again limited to members of the research team who 
have completed VT Human Subjects Protection Training. 
     All data and participant binders will be stored in a safe place to protect confidential 
participant information. Safe places will include locked filing cabinets or locked rooms 
accessible only to study personnel. The full names of participants will not be listed on the 
outside of binders to protect confidentiality of study participants. Electronic data will be saved 
in secure, limited access shared drives on password-protected computers accessible only to the 
research team. 
     Access to study data will be limited to study personnel who have completed the Virginia 
Tech IRB Human Subjects Tutorial and who have been delegated the responsibilities of data 
collection, management, or analyses by the PI. Data collected from this study will be retained 
and destroyed in accordance with the center's policy that requires a 3-year retention period 
following final publication of the data. 
Participant Compensation 
Compensation for participation will be as follows: 
             $20.00 for completion of informed consent   
             $40.00 for completion of each purchase session (3 total in Study 1 and 2 total in Study 2)   
             $40.00 for completion of the follow-up session 
             $30.00 study completion bonus  
         Combined, the subjects could earn up to approximately $210 in Study 1 and $170 in Study 
2 by completing all aspects of the experiment.  

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In addition, participants will receive approximately $5 to $40 each purchase session to purchase 
cigarettes. The amount each participant receives will be proportional to his/her real-world 
cigarette expenditure. In Study 2, it may also be smaller or larger depending on the account 
balance condition drawn. Account balances provided as part of the study to purchase study 
tobacco products will not be advertised as or considered compensation.