Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability: Study 7
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in purchasing in the Experimental Tobacco Marketplace
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants will not be told which cigarettes (ventilated or unventilated) are which.
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in purchasing in the Experimental Tobacco Marketplace
时间窗: Three, six, and nine days after the first consenting session.
The number of tobacco products purchased in the Experimental Tobacco Marketplace for each account balance trial.
次要结局
未报告次要终点
研究者
Jeffrey Stein
Professor
Virginia Polytechnic Institute and State University
