Clinical Laboratory: Examining User Behavior

Using user behavior data collected in the clinical laboratory to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action

Project 2’s (Project Director: Dr. Alison Breland) specific aims are to use established clinical laboratory methods to examine, in independent studies each involving exclusive ECIG users and non-ECIG using smokers, the extent to which subjective effects, puff topography, liquid consumption and nicotine delivery are influenced by three potential regulatory actions: (1) limits on liquid nicotine concentration, (2) constraints on nicotine flux and (3) reduction in flavor availability. Project 2 is informed by the Contextual Knowledge Core (Core Director: Dr. Pebbles Fagan) that ensures independent variables reflect real-world conditions.

Results will provide new data regarding the role of nicotine concentration, flux and flavor availability on ECIG user behavior, while informing population-level predictions. Project 4’s prospective cohort survey (Project Director: Dr. Joanna Cohen) examines these predictions at the population level. Thus, this project is part of a center with an integrative theme of impact analysis that draws from the team’s clinical lab expertise to provide FDA tools that can be used to guide regulation development so that, by the time a regulation goes into effect, methods predictive of population-level phenomena have tested it, refined it and generated data that show its health-promoting effects are maximized and unintended consequences are minimized.

This research is supported by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration under Award Number U54DA036105. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration