Clinical Laboratory: Assessing Abuse Liability

Using abuse liability data to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action

Project 3’s (Project Directors: Dr. Caroline Cobb and Dr. Andrew Barnes) specific aims use standard abuse liability assessments to examine, in independent lab studies each involving exclusive ECIG users and dual ECIG and tobacco cigarette users, the extent to which responding to a battery of behavioral economic tasks is influenced by three potential regulatory actions:  (1) limits on nicotine, (2) constraints on nicotine flux and (3) reduction in flavor availability. Project 3 is informed by the Contextual Knowledge Core that ensures that independent variables reflect real-world conditions.

Overall, results from Project 3 will provide new data regarding ECIG abuse liability in two populations that will likely be impacted by regulatory action differently, and it also will inform testable predictions regarding the consequences of three potential regulatory actions. Project 4 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 abuse liability expertise to provide FDA tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it and generate 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