About the Pilot Project program
CAsToR’s Career Enhancement Core (CEC) aims to foster opportunities for junior investigators to direct research through a pilot project program, in turn supporting applications for extramural funding. Open to new and early-stage investigators, this program supports projects which generate research which can guide the regulatory goals of the FDA’s Center for Tobacco Products, Office of Science. Applicants are encouraged to build networks across TCORS Centers and foster career development plans through this program.
To date, we have funded 27 pilot projects led by graduate students, postdoctoral fellows, and early-stage investigators. Details regarding current and past pilot projects can be found below.
We are no longer accepting submissions for the Fall 2024 deadline. We anticipate releasing our next RFA in Fall 2025.
2025 Funding Cycle Awardees
View other award years: 2025 • 2024 • 2022 • 2021 • 2020 • 2019
Please note: Listing describes appointments and affiliations at the time of award. Please check our Trainees and Alumni pages for current appointments and affiliations.
- “Impact of E-Cigarette Use on Cigarette Smoking Intensity: Epidemiological and Modeling Insights”
- PI: Dr. Pianpian Cao, Assistant Professor at Purdue University
- Abstract and accomplishments +
- Abstract
- The landscape of tobacco use in the US is changing rapidly, with e-cigarettes now being the second most used tobacco product. Previous studies indicate that e-cigarette use (vaping) may lead to the initiation of cigarette smoking (smoking) among nonsmokers or may help with cessation among current
cigarette users. Modeling studies have investigated vaping’s impact on population health, mainly focusing on overall mortality. Some studies have modeled a complete switch from smoking to vaping, while others examined transitions between smoking and vaping. These studies suggest that vaping
could reduce premature deaths by diverting from smoking. However, none of the modeling studies and very few epidemiological analyses have studied nor accounted for the effects of vaping on smoking intensity (measured as the number of cigarettes smoked per day) -- a crucial factor -- as smoking
intensity is closely linked to health outcomes, such as lung cancer risk and overall mortality. Hence, we propose to examine vaping’s effect on smoking intensity among US youth and adults and to extend an existing individual-based smoking simulation model to create the first model considering both cigarette and e-cigarette use and accounting for changes in smoking intensity.
Specific Aims:
Aim 1: Assess the impact of e-cigarette use on cigarette smoking intensity. While evidence suggests that e-cigarette use affects cigarette smoking, their impact on smoking intensity among youth dual or cigarette-only users who previously vaped remains understudied. Additionally, it is unclear if vaping used as a cessation aid among adult cigarette users may affect the amount of cigarette smoking regardless of quitting. Using data from the Population Assessment of Tobacco and Health (PATH) Study and a multistate transition model, I aim to study trends in cigarette smoking intensity and the impact of e-cigarette use on cigarette smoking use and intensity, characterizing transition rates between smoking intensity levels with and without prior vaping experience and accounting for important individual-level characteristics. PATH’s longitudinal design and its inclusion of both youth and adult populations allow for capturing smoking intensity transition patterns across age groups.
Aim 2: Extend the Cancer Intervention and Surveillance Modeling Network (CISNET) Smoking History Generator (SHG) to simulate jointly e-cigarette and cigarette use patterns, including smoking intensity. The CISNET SHG is a microsimulation model that generates individual smoking histories, including age at smoking initiation, quitting, cigarettes per day, and mortality age, and has been widely used to assess lung cancer outcomes under various tobacco control policies. Using transition probabilities from Aim 1, I will expand the SHG to incorporate e-cigarette use and simulating smoking patterns (initiation, cessation, and intensity) influenced by vaping. This two-product SHG will support future simulation studies of various health outcomes, including lung cancer and COPD, in the context of e-cigarette use.
Dr. Pianpian CaoPurdue University- “The Effect of Zyn Internet Virality on Nicotine and Tobacco Product Sales in the US: An Interrupted Time Series Analysis”
- PI: Ashlynn M. Ruleman, MPH, Doctoral Student at Brown University
- Abstract and accomplishments +
- Abstract
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Oral nicotine pouches (ONP) are an emerging public health concern. Adult ONP
awareness increased from 20% to 47% between 2020 and 2021, and ever-use increased from 3% to 16%.One potential driver of increased ONP awareness and use may be online marketing strategies deployed by major ONP manufacturers, especially Swedish Match. While the prevalence of online discourse surrounding Zyn and other ONPs continues to grow, limited
research has investigated the impact of online discourse subsequent impact on ONP uptake, and use. There is extensive evidence that online tobacco content exposure is associated with uptake of nicotine and tobacco products (NTPs).
The long-term harms of ONP use remain unknown due to their novelty. Recent research has indicated that the majority of individuals using ONPs do so concurrently with other NTPs. As such, ONPs may be facilitating multiple tobacco product (MTP) use and reinforcing nicotine dependence rather than serving as a pathway to reduced harm. Consistent with the risks of extant NTPs such as protonated nicotine e-cigarettes and little cigars, product characteristics of ONPs such as appealing flavors and discrete packaging may serve to recruit tobacco naive consumers. Given these potential risks for public health, research is needed that could support future regulatory action on ONPs.
Although the current prevalence of past 30-day (P30D) ONP use remains relatively low among adults, ONP unit sales increased at a mean rate of 8% per month between 2019 and 2022, including a 62% increase in 2023 alone. Sales data are a real-time measure of consumer behavior and can be used as a proxy for product use. Yet there have been no attempts to link data on the direct effect of online ONP content to consumer purchasing behavior, which could inform timely policy decisions on the marketing and sales of these products. The proposed project seeks to evaluate a natural experiment: the impact of Zyn internet virality on sales of Zyn, other ONP brands, and other NTPs.
Specific Aims:
Aim 1: Determine the inflection point in Zyn’s internet virality. The Zyn internet virality inflection point will be determined by fitting a joinpoint regression model to Google Trends search data. Aim 2a: Examine the discontinuity in sales of Zyn, other ONPs,and other NTPs at the internet virality inflection point. We will use an interrupted time series model to examine trends in four-week aggregates of the Nielsen IQ Scantrack data set for NTP sales prior to and following the virality inflection point. Primary outcomes comprise: a) the change in the slope of NTP sales associated with Zyn internet virality; b) the discontinuity in purchasing behavior at this time point; and c) the estimated impact on total NTP sales based on the counterfactual of the pre-virality slope. We will investigate sales in the 12 months leading up to and following the point of internet virality.
Aim 2: Explore moderation of the effect of Zyn virality on product sales by sociodemographic factors
Ashlynn M. Ruleman, MPHBrown University- “California’s Flavored Tobacco Law and Retail Violations: Associations with College Students’ Tobacco Use”
- PI: Dr. Nora Satybaldiyeva, Postdoctoral Fellow at Stanford University School of Medicine
- Abstract and accomplishments +
- Abstract
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More than one in six US young adults still use tobacco products. Young adults are of important focus for tobacco control because they are at greater risk of tobacco use initiation and transitioning to more frequent use than other adults. College students are of particular interest because they are early
adopters of emerging tobacco products. Furthermore, the spatial clustering of tobacco retailers near college campuses exposes college students to saturated marketing environments that may interfere with tobacco control efforts.
Previous surveys of college students’ tobacco use focused on four-year universities or full-time students. There is a lack of research examining tobacco product use among students enrolled in community colleges and enrolled part-time in four-year universities. California (CA) is an ideal setting for this research as it has the most college students of any US state (approximately 1.6 million individuals aged 18-24. The proposed pilot grant aims to examine trends in tobacco product use among CA college students by conducting secondary analyses of survey data from “Retail Environment for Tobacco and Marijuana in California: Impact on College Student Use” (RO1-CA217165; PI: Henriksen).
CA law restricting sales of flavored tobacco became effective on December 21, 2022, between two independent, cross-sectional surveys of CA college students and retail marketing surveillance in a large random sample of licensed tobacco retailers near colleges conducted under the parent grant. The first wave of the survey was completed by students (n=5693) from 168 college campuses from March 22-July 28, 2022, and the second wave was completed by students (n=4164) from166 college campuses from April 4-August 6, 2024.
Specific Aims:
Aim 1: Examine changes in tobacco product use (i.e., nicotine vapes, cigarettes, hookah, cigars, nicotine pouches) and flavored tobacco product use (i.e., flavored nicotine vapes, menthol cigarettes, flavored cigars, flavored nicotine pouches) among college students after the CA sales law went into effect. Aim 1 will use data from both waves of the cross-sectional surveys and will model changes using time (i.e., survey wave) as the main predictor. Across both waves, 27.2%, 19.1%, 11.6%, 12.3%, and 8.1% students reported past 30-day use of nicotine vapes, cigarettes, hookah, cigars, and nicotine pouches, respectively. Interaction terms for Aim 1 will examine whether changes in students’ tobacco and flavored tobacco use varies by student characteristics.
Aim 2: Test whether retail violations, as indicated by the availability of flavored nicotine vapes in a sample of 901 licensed tobacco retailers near 157 colleges, are associated with higher odds of any vape use and flavored nicotine vape use among CA college students. Aim 2 will use data from the second wave of the cross-sectional student survey in addition to the retailer surveillance data to model student flavored nicotine vape use as a function of retail violations. Most colleges at wave 1 (63.7%) and wave 2 (69.9%) had smokefree air policies that included e-cigarettes. Analyses will control for campus policy, institution type and student characteristics, including housing status. This pilot study will provide timely information about the effect of CA law restricting sales of flavored tobacco on college students’ use of these products. Given that CA’s tobacco control policies are often models for other US states, results from the proposed pilot project will help guide FDA’s regulatory decision-making.
Dr. Nora SatybaldiyevaStanford University School of Medicine- “Extracting & Evaluating Legal Variables to Improve Nicotine Vaping Product Policy Impact Modeling”
- PI: Lauren Tonti, JD, MPH, Legal Epidemiologist at University of Missouri
- Abstract and accomplishments +
- Abstract
- Despite the U.S. Food and Drug Administration (FDA)’s health protective regulatory actions, continued sales of unauthorized nicotine vaping products (NVPs) across many mainstream retailers highlights gaps in our understanding of the factors shaping variation in FDA policies’ effects. To address this, the proposed research will study FDA’s 2020 policy prioritizing enforcement against unauthorized flavored, pod-based NVPs, assessing how and why its effects on NVP sales may have varied across states. This research will consider potential effect modifications from state legal variables, often insufficiently accounted for in causal modeling, to clarify how state regulatory factors modify FDA policies’ effects. Accounting for this is important so that the FDA can understand the maximum and minimum impacts its policy will have given different state policy environments and ultimately allow the FDA to design and implement effective policies to reduce access to unauthorized tobacco and nicotine products.
FDA regulates NVPs in cooperation with states, but regulatory approaches within state jurisdictions can vary significantly. State regulatory structures impacting different points in the nicotine and tobacco product supply chain, that is, wholesalers, distributors, and point-of-sale retailers (“retailers”), may modify FDA regulations’ effects on product sales and distribution across states. While much attention is given to retailers, upstream actors’ behaviors are critical to determining which products reach store shelves. Thus, understanding the behavioral incentives and restrictions across the NVP supply chain is necessary to predict how FDA policies will affect access to unauthorized products.
Although all U.S. states require licensing or permitting for cigarette distributors and/or wholesalers doing business in their state, less than half of U.S. states have such requirements for NVPs. We hypothesize that state-level regulations governing wholesalers and distributors will modify the effects of FDA’s NVP policies. To test this, we will use legal epidemiologic methods to document U.S. states’ NVP wholesaler and distributor regulations, and econometric analyses to estimate consequent effect modification on FDA’s 2020 enforcement policy.
Specific Aims:
This study extends existing models by quantifying legal variables, creating a new, comprehensive dataset that can be integrated into other models, and demonstrating how state-level modifiers may influence the effectiveness of FDA policies. Specifically, this study will:
Aim 1: Create and code legal variables documenting state regulation of NVP wholesalers and distributors. Legal epidemiologic methods will be used to create a database of state laws and regulations impacting NVP providers (e.g. licensing and compliance regulations) in 20 U.S. jurisdictions requiring licensing for NVP wholesalers and/or distributors. These qualitative data will be transformed into quantitative variables to characterize variation and facilitate statistical analyses.
Aim 2: Test how state regulatory structures modify the impact of FDA policies across states, particularly in terms of unauthorized NVP sales. Matching Aim 1’s state regulation database to data on nicotine and tobacco product sales, we will estimate effect modification analyses to assess the extent to which state regulation of NVP wholesalers and distributors modified the impact of FDA’s 2020 restriction on different types of NVP sales (e.g., flavored pod-based NVPs, tobacco- or unflavored pod-based NVPs, flavored disposable NVPs, and tobacco- or unflavored disposable NVPs).
Lauren Tonti, JD, MPH University of Missouri- “Comprehensive Analysis of Oral Nicotine Pouch Policies in the U.S.”
- PI: Nargiz Travis, MPH, Project Director at Georgetown University
- Abstract and accomplishments +
- Abstract
- Oral nicotine pouches (ONPs) are a newer class of noncombustible nicotine products that have been available in the US since 2016. In recent years, the popularity and sales of ONPs in the U.S. have rapidly risen. The wide range of flavors makes ONP particularly attractive to youth. Although the FDA has not
approved any PMTAs for ONP manufacturers currently, these products are aggressively marketed across various demographics and are increasingly used by youth and young adults. While some states and localities have enacted restrictions on tobacco products, it remains unclear if such restrictions comprehensively capture ONPs in their definition of tobacco products, and the specific product characteristics they target. The same uncertainty applies to other tobacco policies restricting sales and marketing. This information gap and heterogeneity in legislation create significant challenges for simulation modeling attempting to gauge the impact of ONPs on tobacco use behavior and other population-level outcomes. In particular, it is important to define how these laws apply to ONPs in relation to e-cigarettes and cigarettes.
Specific Aims:
Aim 1: Develop a comprehensive national database of ONP Legislation. The first step will be to identify and define the scope of relevant legislation. This will include identifying both state-level and jurisdictional policies that directly or indirectly regulate ONPs. A systematic review of available legal texts and regulatory documents from all 50 U.S. states, territories, and jurisdictions will be conducted. Once the relevant legislative documents are identified and thoroughly reviewed, the relevant data will be extracted, coded, and organized into a structured database.
Aim 2: Generate inputs of ONP policy variations for simulation modeling. Using the compiled database from Aim 1, relevant policy variables will be extracted, categorized, and standardized to ensure consistency and comparability across different jurisdictions, allowing for their use as inputs in simulation models. Through continuous collaboration with CAsToR modelers, I will identify the types of policy variables and inputs from the database needed for accurate predictions. Input parameters will be integrated into a format that is compatible with existing CAsToR simulation models.
Aim 3: Develop a policy review on the variability in ONP regulations across the U.S. Building on the national database created in Aim 1, I will conduct a comprehensive qualitative analysis of the variability in ONP regulations across the U.S. The analysis will be organized into a framework that categorizes policies based on their type. The findings from the policy analysis will be synthesized into a comprehensive publication. This review will describe the regulatory landscape for ONPs in the US, emphasizing the variability in policies and the potential public health implications of different regulatory approaches. Once completed, the review will be widely disseminated to academic journals, policy stakeholders, and public health agencies. The dissemination will be conducted in collaboration with the CAsToR Policy and Dissemination (PAD) core.
Nargiz Travis, MPHGeorgetown University
View other award years: 2025 • 2024 • 2022 • 2021 • 2020 • 2019