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Rapid Response Human Testing of Smokeless Tobacco Products

Principal Investigator: Pamela Clark

Funding Mechanism: National Institutes of Health- Grant

ID number: 1R01DA31142-01A1

Award Date: 9/1/2012

Institution: University of Maryland College Park

Smokeless tobacco (ST) use is increasing. Since 2005, virtually every major cigarette producer has entered the ST market. The proliferation of new products is adding to the already wide array of available non-smoked tobacco (e.g., moist snuff, chewing tobacco, iqmik, pellets). Characterizing ST products in such a rapidly changing landscape requires a more rapid testing methodology than traditional long-term cross-over trials. The goal of this three-year study is to apply a testing paradigm that relies only on "boost" measures so that products can be tested in single-use sessions. Investigators will perform a series of acute single-blind cross-over trials to characterize and compare the abuse liability potential, likelihood of adoption and potential toxicity of a range of ST products currently on the market. Study aims are: (1) to assess subjects' liking and relief of craving/withdrawal symptoms associated with a variety of ST products and a medical nicotine lozenge (a control with a known low abuse potential); (2) to compare subjects’ neurocognitive function (EEG spectral analysis and event-related potentials) during use of various ST products and medicinal nicotine; (3) to measure and compare boost biomarkers that are sensitive to one-time use of a tobacco product -- including salivary tobacco-specific nitrosamines (TSNAs), polycyclic aromatic hydrocarbons (PAHs) and exhaled breath volatile organic compounds (VOCs) -- before and after a single use of each ST product; and (4) to characterize ST products according to levels of VOCs, TSNAs, PAHs, pH, moisture, total nicotine, and free nicotine. The study population will include 90 adults aged 18 or older with established ST use (defined as using ST products at least daily in the previous month and a history of use for at least a year). Aims 1 through 3 will be accomplished through a series of trials that will each include five smokeless products: four tobacco products with a wide range of free-nicotine levels and toxicants and a medicinal nicotine lozenge (Commit). Aim 4 will be accomplished via measurements of VOCs, TSNAs, PAHs, total nicotine, and free nicotine, pH and moisture levels. All of these results will be used to inform testing of breath and saliva samples obtained before, during, and after use of ST and medicinal nicotine. This research creates a new testing paradigm for rapid, high throughput, acute human testing of ST products.

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