Most disease and disability associated with smoking is secondary to chronic exposure to toxicants, and much of what drives that chronic exposure is addiction to nicotine. Attractive tobacco products encourage experimentation, uptake and maintenance. Nicotine is primarily responsible for addiction to cigarettes, but with highly engineered nicotine delivery devices, other design characteristics (e.g., addition of flavorants, manipulation of smoke pH, degree of filter ventilation, etc.) can interact with nicotine to promote attractiveness (or lack of attractiveness) and affect continued use. Learned associations between nicotine and other sensory characteristics of cigarettes contribute to the rewarding characteristics of smoked tobacco products. This is a proposal to characterize and contrast consumer acceptability and likelihood of adoption of combustible tobacco products by comparing neurocognitive function, as indexed by event-related brain potentials (ERPs), in response to smoking test cigarettes with and without characteristics of interest.
The second aim i s to determine the contribution of "throat grab" to tobacco product acceptability and likelihood of adoption. The primary outcome measures will be changes in latency and amplitude of ERPs before and after smoking of test cigarettes. Potential covariates are age, race, gender, and dose (indexed by nicotine boost and total puff volume). The design of this Tobacco Center of Regulatory Science is such that the products to be tested are not known in advance, so we base this on a model of testing cigarettes with and without characterizing levels of menthol and with high versus low pH.
The aims will be accomplished through a series of within-subjects crossover trials;each trial will include the test tobacco product and comparison product, in four laboratory smoking sessions. These illustrative studies will include, with two separate cohorts: comparison of high and low pH products, with and without throat anesthetization, and comparison of menthol and non-menthol cigarettes with and without throat anesthetization, all in separate laboratory visits, with EEG recording before, during and after smoking, and for ERPs, an odd ball task performed before and after smoking.
There is little information about where individual products fall within a harm continuum. It is apparent that the central nervous system effects of cigarettes vary by dose of nicotine, the form that nicotine takes, tobacco additives and use behaviors. This is a proposal to characterize the CNS effects of standard, new and/or manipulated combustible tobacco products to provide the FDA CTP with a science basis for regulation.
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