Clinical trial NCT03496922: Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7
Official title: Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Unventilated Cigarettes
Experimental Tobacco Marketplace
Demand
Delay Discounting
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* provide written informed consent,
* be 18-65 years of age,
* be an active smoker,
* report smoking daily in the past month,
* have stable self-reported mental and physical health,
* be willing to try unventilated cigarettes or alternative nicotine products.
* report that their usual brand of cigarettes features \>\~20% filter ventilation (i.e., "ultra light" and "light" varieties).

Exclusion Criteria:

* trying or have immediate plans to quit smoking,
* currently using a prescription medication that might affect smoking or nicotine metabolism (e.g., varenicline, bupropion),
* have plans to move away from the area,
* 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.

Primary outcomes:
measure: Change in purchasing in the Experimental Tobacco Marketplace
timeFrame: Three, six, and nine days after the first consenting session.
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Addiction Research Recovery Center - Virginia Tech
name: Warren K Bickel, PhD
role: PRINCIPAL_INVESTIGATOR
References: