# Project 3: Using abuse liability data to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action

> **NIH NIH U54** · VIRGINIA COMMONWEALTH UNIVERSITY · 2022 · $413,398

## Abstract

Project Summary. The Center for the Study of Tobacco Products (CSTP) has developed a model for
evaluating novel tobacco products using, as exemplars, electronic cigarettes (ECIGs) that heat a liquid that
often contains nicotine, forming an aerosol that users inhale. Now, CSTP leverages this ECIG expertise to
pivot from product evaluation to an integrative theme of impact analysis. Specifically, the CSTP proposes
methods with which FDA can generate predictions regarding a potential regulation’s effects and then whether
or not the predicted effects occur in the population can be tested. The CSTP’s model assesses how potential
regulation might influence product toxicity (Project 1), user behavior (Project 2), and product addiction/abuse
liability (Project 3). In this context, Project 3 will generate new data regarding the abuse liability of advanced-
generation ECIGs and will contribute, along with Projects 1 and 2, to population-level predictions. Project 4 will
test those population-level predictions.
FDA regulations are intended to promote health, but also may have unintended consequences. For example,
limiting ECIG liquids to <20 mg/ml nicotine, as in the European Union (EU), can drive use of higher power
devices that aerosolize more liquid/puff, leading users to inhale more nicotine. Unintended consequences may
also occur from other actions, such as constraining ECIG nicotine flux (rate of nicotine emission), or reducing
flavored ECIG liquid availability. The consequences of these and other potential regulations on ECIG use and
dependence can be predicted by assessing abuse liability, or likelihood of persistent drug use/dependence.
Behavioral economic tasks are validated indicators of abuse liability and reveal how much people are willing to
pay for a drug, how hard they will work to earn a drug, and how sensitive they are to changes in drug prices.
Project 3 specific aims use standard abuse liability assessments to examine, in independent lab studies each
involving 60 exclusive ECIG users and 60 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 regu...

## Key facts

- **NIH application ID:** 10477273
- **Project number:** 5U54DA036105-10
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Caroline O Cobb
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $413,398
- **Award type:** 5
- **Project period:** 2013-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10477273

## Citation

> US National Institutes of Health, RePORTER application 10477273, Project 3: Using abuse liability data to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action (5U54DA036105-10). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10477273. Licensed CC0.

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