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.
2024 Funding Cycle Awardees
View other award years: 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.
- Title: “Exploring Multiplicative Interactions of Marketing and Disparity Identities on Tobacco Use Behaviors”
- PI: Dr. Zongshuan Duan, Assistant Professor at Georgia State University
- Abstract and accomplishments +
- Abstract
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Background: The evolving US tobacco marketplace employs diversified marketing strategies, disproportionately targeting disadvantaged populations. Despite existing knowledge on tobacco-related disparities, literature faces several limitations. First, there is limited research exploring the role of intersectionality in disparities. Second, there is insufficient knowledge of the broad spectrum of tobacco products and multiple tobacco product (MTP) use among minorities and those with intersecting minority identities, particularly in longitudinal or nationally representative studies. Third, limited research has examined the potential multiplicative interaction role of marketing exposure, which may exacerbate disparities in tobacco use among minorities and those with intersecting minority identities. Addressing these gaps is crucial for developing targeted policies and interventions to promote health equity. This proposal aims to examine whether and to what extent tobacco marketing and disparity identities may multiplicatively affect their tobacco use behaviors among US youth and young adults.
Specific Aims:
In this pilot study, we will focus on analyzing population-based longitudinal data from the Population Assessment of Tobacco and Health (PATH) study, to address 2 aims:
Aim 1: Examine tobacco use behaviors over time (i.e., tobacco product use, MTP use, flavored product use) among youth and young adults representing disparity identities and intersecting disparity identities.
Aim 2: Examine whether and to what extent exposure to tobacco marketing may differentially affect tobacco use behaviors among youth and young adults representing minorities and intersecting disparity identities.
Dr. Zongshuan DuanGeorgia State University- Title: “Understanding the Role of Social Network Dynamics on Adolescent Tobacco and Nicotine Use”
- PI: Dr. Clinton H. Durney, Research Methodologist at British Columbia Cancer Research Institute
- Abstract and accomplishments +
- Abstract
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Tobacco use is a significant public health concern, often beginning during adolescence and early adulthood. Existing research frequently examines tobacco and nicotine use at a broad level, without considering the impact of social interactions. This leaves a gap in our understanding of how knowledge, attitudes, perceptions, and behaviors related to tobacco use spread within social networks. Adolescents are heavily influenced by their social circles, both in-person and online, making them particularly vulnerable to peer influence, viral marketing, and targeted products like flavored tobacco. Recognizing the critical role of network characteristics — such as the arrangement and number of connections, as well as other topological features — in shaping tobacco use dynamics is essential. Understanding these influences is crucial for developing effective prevention and intervention strategies tailored to the unique vulnerabilities of youth.
Specific Aims:
- Investigate Peer Influence:
- We will study how the behaviors and characteristics of friends and social connections affect the initiation and progression of nicotine use among teenagers.
- Using data from large national surveys, we aim to identify key factors that influence teen tobacco use. This includes examining how peer pressure, perceptions of health risks, and the popularity of different tobacco products affect their choices.
- We will assess how the interaction between peer influence and peer selection impacts youth decisions regarding tobacco use.
- Model Social Networks:
- We will develop a dynamic social network model to simulate how social connections evolve over time and how these changes impact tobacco use among teens.
- This model will help us understand the role of different network features, such as the number and arrangement of connections and the formation of friend groups, in shaping tobacco use behaviors.
- By analyzing these network characteristics, we aim to determine how they influence the likelihood of adolescent’s initiation of tobacco products.
- Explore Key Influences:
- We will delve deeper into how various factors, such as environmental influences and psychosocial aspects, interact with peer influences to shape adolescent smoking behaviors.
- Our model will incorporate these factors to refine the probabilities of transitioning to tobacco use within social networks.
- We will simulate different theoretical scenarios to explore how changes in social networks and smoking habits co-evolve. This includes examining how friends' smoking behaviors influence individual decisions and how network restructuring processes impact overall tobacco use trends.
- Investigate Peer Influence:
Dr. Clinton H. DurneyBritish Columbia Cancer Research Institute- Title: “Estimating Unbiased and Precise Effects of Oral Nicotine Product Use on Inhaled Tobacco Product Use Persistence and Progression in Adolescence”
- PI: Dr. Dae Hee Han, Postdoctoral Scholar at University of Southern California
- Abstract and accomplishments +
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Background: Non-tobacco oral nicotine products (ONP) are a relatively new type of commercial tobacco product and one of the fastest-growing commercial tobacco product categories in the U.S. market. During 2019–2022, U.S. sales of nicotine pouches, one of the most prevalent ONPs among U.S. adolescents, have increased by 540% (from 126 million units to 808 million units). ONPs may be of particular interest to young people who use inhaled tobacco products (ITPs; e.g., combustible cigarettes and e-cigarettes) because ONPs can be used discreetly where ITP use is not allowed. Due to these concerns and adverse health effects of ONP use (e.g., oral toxicity), it is important to understand whether ONP-ITP co-use promotes ITP use persistence and progression among adolescents who use ITPs.
Inverse probability weighting (IPW) has been one of the most widely used approaches to reduce confounding effects in epidemiologic and public health research. Augmented inverse probability weighting (AIPW) combines both the properties of the regression-based estimator (balancing differences in outcomes) and IPW estimator (balancing differences in exposure) and is therefore a “doubly robust” method in that it requires only either the propensity or outcome model to be correctly specified but not both. Machine learning can be used to enhance AIPW (AIPW-ML) to produce more accurate standard error estimates, narrowing the confidence interval (CI) for exposure effect estimates, improving statistical accuracy and efficiency. Yet, AIPW-ML has never been applied in tobacco regulatory science research, including analysis of ONP use effects on subsequent ITP use patterns.
Specific Aims:
Aim 1: Examine the association of ONP and ITP co-use with subsequent ITP use persistence and progression using a conventional IPW approach. The average treatment effects of ONP-ITP co-use on ITP persistence and progression among adolescents will be estimated using a conventional inverse probability weighting approach in which participants are weighted by the inverse probability of their treatment assignment (i.e., ONP co-use). Hypothesis: Among adolescents who used ITPs at baseline, those with (vs. without) baseline ONP co-use would be more likely to continue to use ITPs and increase ITP use frequency at follow-up.
Aim 2: Examine the association of ONP-ITP co-use with subsequent ITP use persistence and progression using machine learning enhanced augmented inverse probability weighting (AIPW-ML) and compare estimates to Aim 1 results. We will use AIPW-ML that estimates less biased average treatment effects of adolescent co-use of ONP and ITP on ITP use persistence and progression. We will use the ensemble (i.e., super learner) algorithm for machine leaning analysis. Hypothesis: 95% CIs of ONP co-use effect estimates using AIPW-ML will be narrower than those estimated using the conventional IPW.
Dr. Dae Hee HanUniversity of Southern California- Title: “A Machine Learning Approach to Cluster Similar Flavors of Electronic Nicotine Delivery Systems”
- PI: Dr. Mona Issabakhsh, Research Instructor at Georgetown University
- Abstract and accomplishments +
- Abstract
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Background: Despite a significant decline in smoking rates, cigarette use remains a leading cause of preventable mortality in the US, responsible for 480,000 deaths annually. Smoking uptake prevention and smoking cessation are among the most cost-effective and powerful solutions for tobacco-related disease prevention. Of US adult tobacco users, 24% use electronic nicotine delivery systems (ENDS). ENDS are available in hundreds of flavors beyond tobacco, which is one of the most commonly reported reasons for their use. The wide variety of ENDS flavors is a persistent concern among policymakers since studies indicate that flavored ENDS attract youth to ENDS use with the risk of subsequent cigarette initiation. Flavored ENDS use may also encourage cigarette smoking cessation; flavors, such as fruit, dessert, and menthol, have been reported to attract adult smokers trying to quit or reduce cigarette use. Studies, however, reported outcomes ranging from no effect to a significant positive effect for the association between flavored ENDS use and smoking cessation. The range of outcomes reported in the literature may stem from the wide variety of ENDS flavors and the heterogeneity of their users. Therefore, a systematic classification of ENDS flavors (considering flavor types, user characteristics, and ENDS devices) can improve empirical studies and simulation models' accuracy and increase the comparability of research results. The proposed research will apply machine learning (ML) clustering models to distinguish related clusters of ENDS flavors using the Nielson consumer panel data.
Specific Aims:
Aim 1: Develop a flavored ENDS clustering model based on flavor types, devices, and user characteristics. To develop a clustering model, first, a variable selection step will be performed, which determines essential features to assign the most similar flavors to the same cluster while assigning the least similar flavors to separate clusters. Variables will include flavor types, ENDS devices, and consumers’ characteristics and will be inputted into the variable selection analysis to find the best subset of variables to develop an optimized clustering model. The most significant variables will be selected using an efficient tree-based algorithm that applies a “decision tree” structure to determine variable importance.
Aim 2: Train the flavored ENDS clustering model. Using the selected important variables, the dissimilarities between ENDS flavors will be calculated using the Gower distance method, a measure used to calculate the distance between two data points whose attribute has a mix of categorical and numerical values. The sample will be divided into a training and a testing dataset. The training dataset will be used to “train” the model, while the testing dataset (which shares the same distribution and properties as the training dataset) will be used to test the model's accuracy.
Aim 3: Test and validate the flavored ENDS clustering model. The trained model will cluster the testing set instances (i.e., unclustered data). The model's performance will then be evaluated by assigning the most similar flavors of ENDS to the same cluster or, in other words, minimizing dissimilarity within each cluster. While the model will be internally validated using a testing set, external validation can be done by developing ENDS clusters using the latent class analysis (LCA) statistical approach and comparing the results to the literature that has developed ENDS flavor categories.
Dr. Mona IssabakhshGeorgetown University- Title: “Impact of Flavored E-Cigarette Use and Nicotine Metabolism on Systemic Inflammatory Biomarkers of Cardiovascular Disease Risk”
- PI: Dr. Nancy Jao, Assistant Professor at Rosalind Franklin University of Medicine and Science
- Abstract and accomplishments +
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Background:
In 2020, the United States (US) Food and Drug Administration (FDA) issued a new enforcement policy against the sale of certain flavored e-cigarette (EC) products in an effort to limit the popularity of flavored ECs among youth, especially fruit and mint flavors. However, the overall use of flavored ECs has continued to increase since the implementation of the FDA policy.
Additionally, despite the efforts to curb flavored EC use among youth, the 2022 National Youth Tobacco Survey found that 84.9% of high and middle school students who use ECs prefer flavored ECs, including a rise in menthol-flavored EC use. With the continued rise of flavored ECs, it remains vital for the FDA to continue to prioritize understanding how flavored EC use can impact overall public health.
Although the use of combustible cigarettes has been long connected to increased risk for cardiovascular disease (CVD), the investigation of the short- and long-term health effects of EC use is still emerging. One important gap in the literature is the understanding of e-cigarette use with subclinical CVD outcomes in well-defined longitudinal cohorts. Although basic science studies have shown that flavoring in EC products can lead to increases in inflammatory response and dysfunction beyond the effects of nicotine, no studies to date have examined whether flavored EC use may increase CVD risk compared to unflavored (i.e., tobacco) EC use.
Individual differences in nicotine processing not only influence smoking behavior but also have direct implications for adverse health outcomes. As individuals adjust their smoking behavior based on their rate of nicotine processing, individual differences in nicotine processing have been shown to play a role in influencing clinical outcomes. The nicotine metabolite ratio (NMR) is a validated phenotypic biomarker measurement of nicotine processing and clearance. However, while flavored EC use has been shown to suppress NMR to prolong the duration of nicotine bioavailability, no studies to date have examined how flavored EC use may impact NMR to impact levels of systemic inflammation.
Specific Aims:
The proposed study will examine the potential role of flavored EC use and NMR on biomarkers of CVD risk in the Population Assessment of Tobacco and Health (PATH) Study conducted by NIH/FDA. Specifically, the proposed study will examine population-level differences in systemic biomarkers of inflammation and nicotine processing between individuals who use flavored vs. unflavored ECs. The specific aims of this project are to:
Aim 1: Assess the direct and interactive effects of EC type (flavored vs. unflavored) and NMR on levels of systemic inflammation at Wave 1. Hypothesis: Individuals who use flavored ECs with slower NMR will have higher levels of systemic inflammation.
Aim 2: Compare the level of risk for CVD diagnosis based on flavored EC use and NMR at baseline and follow up waves. Hypothesis: Individuals who use flavored ECs and have slower NMR will have a greater likelihood of CVD diagnosis at Wave 1 and follow up Waves.
Dr. Nancy JaoRosalind Franklin University of Medicine and Science- Title: “Forecasting the Impact of a U.S. Nicotine Reduction Standard on People with Disabilities”
- PI: Dana Rubenstein, MHS, Medical Student at Duke University School of Medicine
- Abstract and accomplishments +
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Background:
People with disabilities use tobacco at disproportionately high prevalences and experience the greatest burden of related morbidity and mortality. National survey data show that adults with disabilities—including those with physical, cognitive, sensory, and other functional impairments—are significantly more likely to smoke cigarettes than adults without disabilities. This elevated prevalence contributes to persistent health disparities, including increased risk of cardiovascular disease, cancer, and premature death.
One public policy approach that may reduce smoking and improve outcomes in people with disabilities—and in the U.S. population overall—is a nicotine reduction standard (NRS). This approach is based on nearly a decade of clinical trials demonstrating improved smoking outcomes for individuals randomized to very low nicotine content (VLNC) versus normal nicotine content cigarettes. The NRS was announced as a potential proposed rule by the U.S. Food and Drug Administration (FDA) in 2022 and remains under consideration.
While the net public health impact of an NRS is anticipated to be groundbreaking (e.g., estimated to drop U.S. smoking prevalence from 12% to <2%), it is unclear whether these benefits will be equitably distributed. In particular, people with disabilities face unique structural, social, and economic barriers to cessation and may experience different outcomes under such a policy. Although clinical trials have shown positive effects of VLNC cigarettes in several tobacco disparity populations, the long-term effects of an NRS in people with disabilities—a large, heterogeneous, and underserved group—remain unknown.
Specific Aims:
The objective of this study is to extend the Mendez-Warner simulation model—a well-established model of smoking prevalence and public health effects—to adults with disabilities, a priority population with disproportionately high tobacco burden. In particular, we will look at adults with disabilities overall and specific types of disabilities, such as mobility, hearing, vision, and cognitive disabilities, as well as number of disabilities. Aims 1-3 will be replicated within each of these groups.
Specifically:
- Aim 1: Acquire relevant input parameters (e.g., smoking prevalence, net cessation rate, and initiation rate) for adults with disabilities using nationally representative datasets such as the National Health Interview Survey (NHIS).
- Aim 2: Use the Mendez-Warner simulation model to project smoking prevalence and public health harms from 2023–2100 in people with disabilities, with and without implementation of an NRS.
- Aim 3: Evaluate the potential public health benefits of an NRS for people with disabilities.
- Aim 3.1: Compare projected outcomes under the NRS versus no-NRS scenario to quantify the potential impact in this population.
- Aim 3.2: Compare projected outcomes in people with disabilities to those in the overall U.S. population to assess equity in policy effects.
Dana Rubenstein, MHSDuke University School of Medicine