TCORS 2.0: Center for the Assessment of Tobacco Regulations (CAsToR)

Pilot + Feasibility

About the Pilot + Feasibility program

The Carer 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 develop career development plans through this program.

To date, we have been able to fund 14 pilot projects led by graduate students, postdoctoral students, and early stage investigators. Details regarding current and past pilot projects can be found below.

We are no longer accepting applications for the current pilot funds cycle (2020-2021). Please check back for additional information regarding the next application cycle. For questions, please contact Katie Zarins (kmrents@umich.edu).

2020 Funding Cycle Awardees

Please note: Listing describes appointments and affiliations at the time of award. Please check our Trainees page for current appointments and affiliations.

Title: “Determinants of tobacco use transitions among smokers and dual users of cigarettes and e-cigarettes”
PI: Dr. Andrew Brouwer, Assistant Research Scientist at University of Michigan
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Dr. Andrew Brouwer
Dr. Andrew BrouwerUniversity of Michigan
Abstract
Introduction: The introduction of e-cigarettes has dramatically changed the landscape of tobacco products and product-use patterns in the U.S. A systems approach can help to understanding transitions between different tobacco use states (e.g., never use, current single product use, current dual product use, non-current use).

Aims:

Aim 1: Apply Markov transition models to the Exhale longitudinal cohort study of smokers and dual cigarette and e-cigarette users, estimating baseline transition rates and differences in transition rate by demographic (e.g., age, gender, race/ethnicity), smoking behavior (e.g., duration of smoking and vaping), smoking dependence (e.g., time to first cigarette, cigarettes/day), and smoking biomarker measures (e.g., cotinine and NNAL).

Aim 2: Leverage the frequent measurements (every 4 months) in the Exhale study to assess the association between time in a state and probability of transition, by using a generalized Markov state model with a time-instate variable. Methods: We will use multistate transition modeling and data from the University of Wisconsin Exhale study, an existing longitudinal cohort of smokers and dual users.

Anticipated results: We expect to quantify how transition rates between different tobacco use states depend on sociodemographics, smoking behavior, smoking dependence, smoking biomarkers, and the length of time since one’s last transition.

Implications: Understanding rates and determinants of product-use transitions of cigarettes and e-cigarettes will help to determine what kinds of tobacco control policy will be effective and aid in future projections of use and incidence of downstream health effects.
Accomplishments
Coming Soon!
Title: “Modeling the Effects of E-cigarette Use on Smokers with Comorbid Major Depression”
PI: Dr. Jamie Tam, Assistant Professor at Yale University
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Dr. Jamie Tam
Dr. Jamie TamYale University
Abstract
Introduction: Smoking rates remain unacceptably high among those with mental health conditions, including those with major depression. E-cigarettes have the potential to alter this trajectory, but their long-term impact on the health of vulnerable populations is unknown.

Aims:

Aim 1: Simulate e-cigarette use patterns and smoking-related mortality among adults with MD from 2020-2100.

Methods: This study will adapt a previously developed smoking and major depression model to account for e-cigarette use and its potential effects on smoking among people with MD. The resulting microsimulation model would integrate smoking initiation and cessation inputs generated by the Cancer Intervention and Surveillance Modeling Network (CISNET) smoking history generator (SHG), as well as recently published MD incidence, recovery, and recurrent parameters to simulate individual-level trajectories of smoking and MD in the population. Using available literature estimates, three key e-cigarette use parameters would be evaluated for the MD population: (1) the effect of current cigarette smoking on subsequent e-cigarette initiation, (2) the effect of current e-cigarette use on subsequent smoking initiation, and (3) the effect of current e-cigarette use on smoking cessation.

Anticipated Results: Estimates of projected smoking and vaping prevalence and related mortality and life years lost associated with e-cigarette use in the population with MD, with plausible parameter ranges evaluated for best case “optimistic” scenario and worst case “pessimistic” scenarios from 2020-2100.

Implications: This simulation model would integrate the best available epidemiological data and inputs to help the FDA understand the range of possible outcomes associated with e-cigarette use in a specific vulnerable population: adults with current MD. The model would eventually be applied to examine the impact of FDA policies on this specific populations, including regulations that affect the design, content, and appeal of e-cigarettes and cigarettes.
Accomplishments
Coming Soon!
Title: “Impact of prohibiting characterizing flavors in nicotine vaping products”
PI: Dr. Kai-Wen Cheng, Assistant Professor at Governors State University
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Dr. Kai-Wen Cheng
Dr. Kai-Wen ChengGovernors State University
Abstract
Introduction: Flavors in Nicotine Vaping Products (NVPs) have particularly strong appeal to youth and young adults, vulnerable subgroups for initiating tobacco use and experimenting with multiple products. Among both youth and adults, flavors continue to be a significant factor explaining the use of NVPs. Recently, several state and local jurisdictions, including Michigan, Minneapolis, Boston, Berkeley, Oakland, and San Francisco, have implemented characterizing flavor bans on NVPs. Bans at the state and local level provide an opportunity to assess the impact of prohibiting characterizing flavors on use of flavored and non-flavored nicotine products.

Aims: Estimate the impact of characterizing flavor ban on NVPs on use, discontinued use, and switching between products. Study the impact of the current characterizing flavor ban on sales/purchase/use of restricted flavored and unrestricted flavored and non-flavored nicotine products.

Methods: Synthetic control and difference-in-difference approaches will estimate whether and to what extent prohibiting characterizing flavors a) reduced sales, purchase, and use of restricted flavored products; b) increased sales, purchase, and use of unrestricted other products; c) increased switching to other unrestricted products; and d) decreased use of any nicotine products.

Anticipated Results: Hypotheses include that the prohibition of flavored NVPs will (1) decrease sales/purchase/use of flavored NVPs, (2) increase sales/purchase/use of non-flavored NVPs, (3) increase sales/purchase/use of flavored other products (e.g. mentholated cigarettes and flavored cigars), and (4) decrease use of any nicotine products.

Implications: The assessment of prohibiting characterizing flavors on NVPs is timely and significant, as the FDA intends to prohibit characterizing flavors in all types of NVPs. Furthermore, this study will advance the science of impact analysis by providing accurate estimates that can be applied to evaluate the economic impact of prohibiting characterizing flavors in all nicotine products, such as cigarettes, cigars, and NVPs.
Accomplishments
Coming Soon!
Title: “Examine and model the impact of e-cigarette ban”
PI: Dr. Yong Yang, Assistant Professor at University of Memphis
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Dr. Yong Yang
Dr. Yong YangUniversity of Memphis
Abstract
Introduction: Flavor bans have been under discussion over years and have been recently heightened. The outbreak of lung injury associated with e-cigarette use in 2019 has led the Food and Drug Administration (FDA), several cities and states to consider banning all or some e-cigarette sales. At the beginning of 2020, FDA banned the sale of fruit and mint flavored e-cigarettes but the ban did not apply to menthol and tobacco flavored products. A key challenge for FDA and other tobacco control regulators is how to regulate flavors effectively to maximize public health gains while minimizing related public health losses.

Agent-based models (ABM), as a promising systems science tool, have the potential to help to achieve the right public health balance. However, An ABM to examine the impact of a flavor ban demands a comprehensive knowledge of tobacco use behavior at the individual level. In this study, we propose to expand and strengthen our knowledge on tobacco/e-cigarette use behavioral change responding to flavor ban policy, and the knowledge will be tailored and ready to use for an ABM.

Aims:

Aim 1: Assess the empirical changes in different types of e-cigarette and other tobacco use by key subpopulations in several states that have recently implemented flavor bans.

Aim 2: Use discrete choice experiments to estimate people’s responses to hypothetical presentations of the major different types of vaping or flavored product bans.

Methods: For Aim 1, we will use an online crowdsourcing platform to conduct surveys in several selected states. Besides basic demographics, perceptions of the relative risk of different types of tobacco products, we will collect the current (30 days preceding the survey) and previous (before the flavor ban enforcement) status on smoking and vaping, quit motivation, accessibility, retailer environment, social support for tobacco use, and residential zip code as a proxy of the neighborhood. Multinomial logistic regression models will be used to analyze the determinants of participants’ tobacco use change.

For Aim 2, we will a series of the discrete choice experiment (DCE) to estimate consumer response to hypothetical flavor bans. We aim to examine several flavor-related ban policies. For the DCE data, we will take each option among the choice set as an observation and use multinominal logistic regression models to estimate the effect of each attribute on a user’s demand for tobacco/e-cigarette products. Anticipated Results: Aim 1 will provide the actual patterns of tobacco use change under various empirical policies context, and Aim 2 will provide stated preferences of tobacco use change under various hypothetical policies environment. The two results will be complementary to each other and be used for future modeling purpose.

Implications: Both aims are independent research on their own, and at the same time, they will provide input for ongoing ABM research. In the future, we will develop and extend the ABM to examine the effect of the flavor ban at city, state, and federal levels, among young adults, youth, and the general population.
Accomplishments
Coming Soon!
Title: “Substitutability of cigarettes for salt- and free-based ENDS devices in young adult ENDS users”
PI: Dr. Amanda Quisenberry, Assistant Professor at Roswell Park Comprehensive Cancer Center
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Dr. Amanda Quisenberry
Dr. Amanda QuisenberryRoswell Park Comprehensive Cancer Center
Abstract
Introduction: The recent increase in electronic nicotine delivery systems (ENDS) use among youth and young adults and associated nicotine dependence may increase the risk for uptake of other tobacco products. We must understand both the conditions in which young users of ENDS may switch to using cigarettes, which are more toxic, and the associated regulatory efforts that may curb these transitions to protect the health of these young people.

Aims:
Specific Aim 1: To determine the abuse liability of salt-base and free-base ENDS in young exclusive ENDS users of each ENDS e-liquid type.
Specific Aim 2: To determine the substitutability of combustible cigarettes for salt-base and free-base ENDS among users of each ENDS e-liquid type when menthol cigarettes are and are not available.
Specific Aim 3: To determine which demographic and psychosocial characteristics mediate the level of abuse liability and substitutability determined in Aims 1 and 2.

Methods: Participants who are salt- (n=25) and free-base (n=25) ENDS users will complete two online purchasing tasks when menthol cigarettes are and are not available among the multiple alternative tobacco products available using the Experimental Tobacco Marketplace.

Anticipated Results: We predict that menthol cigarettes will be stronger substitutes compared to non-menthol cigarettes in both salt- and free-base nicotine ENDS users and that salt-base ENDS users will be less likely to switch products. Specific user characteristics, such as delay discounting rate, will be evaluated as modifiers of switching to cigarettes among salt- and free-base ENDS users.

Implications: Regulatory efforts targeting the availability of menthol in cigarettes and other products will be informed regarding the propensity for young adult ENDS users to switch products when flavor availability is restricted.
Accomplishments
Coming Soon!
Title: “Identifying Causal Pathways in Longitudinal Tobacco Product Transition Studies”
PI: Dr. Shu Xu, Clinical Assistant Professor at New York University
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Dr. Shu Xu
Dr. Shu XuNew York University
Abstract
Introduction: The accelerating rate of e-cigarette use among U.S. youth and young adults during the past few years has sparked public health concerns, including the possibility that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults. Therefore, on both counts, it is important to identify risk and protective factors that mediate the transition between e-cigarette and cigarette use and vice-versa.

Aims: The overarching aim of this application is to apply and disseminate causal mediation methods to tobacco research. Specifically, we will apply causal mediation methods to tobacco use data to evaluate the mediational role of harm perceptions that may explain the transition from e-cigarette to combustible cigarette use, and from cigarettes to e-cigarettes.

Methods: We will use Waves 1 - 4 data from the Population Assessment of Tobacco and Health (PATH) project, jointly sponsored by the National Institution on Drug Abuse and several other federal research agencies, to track e-cigarette and cigarette use transitions among youth and adults. We will apply both causal mediation analysis methods (i.e., marginal structural equation models, g-estimation, natural effect models, and nonparametric structural equation models) in addition to the conventional mediation method to assess whether among baseline tobacco naïve participants (Wave 1), ever e-cigarette use (Wave 2) were associated with smoking initiation (Waves 3 - 4) and whether this association can be partially or fully explained by harm perception of tobacco use (Wave 3). Likewise, we will also study the transition from cigarette use to e-cigarette use.

Anticipated results: We will assess the mediated effect of harm perceptions on the transition from e-cigarette use to cigarette use and vice versa, and assess the mediated effect when an interaction between e-cigarette use, cigarette use and harm perceptions exists. We will compare the findings of each method in terms of model assumptions, definition of causal effects, estimates, and precision of estimation.

Implications: The proposed study fills the gap between advances in causal inferential statistics and applied tobacco research. The findings of the proposed study will inform youth prevention and adult cessation efforts by providing insight into trajectories of e-cigarette and cigarette use.
Accomplishments
Coming Soon!
Title: “Assessing the toxicity of DIY additives in response to a flavor ban in ECIG liquids”
PI: Ahmad El-Hellani, Assistant Research Professor at American University of Beirut and Eric Soule, Assistant Professor at East Carolina University
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Eric Soule
Eric SouleEast Carolina University
 
Ahmad El-Hellani
Ahmad El-HellaniAmerican University of Beirut
Abstract
Introduction: The availability off lavors is one of the top reasons for ECIG use initiation, especially among youth and young adults. A growing body of evidence demonstrates that access to appealing ECIG liquid flavors makes it easier to transition to regular ECIG use among those who have tried ECIGs. In response to the identified role of flavors in increasing ECIG appeal, policies restricting flavors in ECIG to menthol and tobacco have been considered or implemented. Previous research has indicated some ECIG users may attempt to make their own ECIG liquids in response to a ban on ECIG liquid flavors, a behavior is known as do-it-yourself (DIY) mixing. Some ECIG users may use ingredients in their DIY ECIG liquids with unknown toxicity when inhaled from ECIG aerosol, including sweeteners, alcohols, or essential oils.

Aims:
Aim 1:Identify compounds that ECIG users may add to their ECIG liquids in response to a restriction on flavors.
Aim 2:Assess the toxicity of DIY flavored ECIG liquids that include additives/recipes identified in Aim1.

Methods: A systematic internet search will be conducted to identify additives (such as sweeteners, cannabinoid (CBD) oil, essential oils, etc.) that may be used in DIY ECIG liquids. These DIY ECIG liquid recipes will be used to generate ECIG aerosol. Reactive oxygen species (ROS) will be measured in the generated aerosol and will be compared to ROS aerosols from standard commercially available ECIG liquids.

Anticipated Results: This project will provide insight into the toxicity of DIY ECIG liquids.

Implications: Consumers’ addition of unregulated chemicals to their liquids represents a major public health concern as research shows that additives like commercial flavors increase the toxicity of ECIG aerosols.
Accomplishments
Coming Soon!
Title: “The Potential Impact of Individual Decision Making and Social Network Structure on TobaccoProduct Regulation Effectiveness and Disparities in Adolescent Tobacco Use Behavior”
PI: Iris Shao, Doctoral Student at Emory University
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Iris Shao
Iris ShaoEmory University
Abstract
Introduction:Several existing tobacco product regulatory actions and changes in tobacco product characteristics, such as required warning messages display on cigarette packaging provide an excellent opportunity for prevention among adolescent tobacco product users. However, evaluating the impact and sustainability of these regulatory actions on long-term adolescent tobacco use behaviors still faces tremendous obstacles, especially given mixed evidence of effectiveness in different target population and persisting disparities among the socially disadvantaged.

Aims:
Aim 1: To estimate the effect of social network structural characteristics on adolescent tobacco use behavior, stratified by sex, race/ethnic, and parental socioeconomic status respectively, using the National Longitudinal Study of Adolescent to Adult Health dataset.
Aim 2: To evaluate potential effectiveness of tobacco product marketplace regulation (e.g. smokeless tobacco/cigarette labeling and warning statement requirement) on adolescents of heterogeneous socio-demographic characteristics, using a systems modeling approach.

Anticipated Results: We hypothesize that high network clustering, density, and in-degree centrality are associated with lower levels of tobacco use; such associations differ by sex, race/ethnicity, and parental socioeconomic status. In addition, we will develop an agent-based model to explore potential long-term effectiveness of different tobacco product regulations, incorporating information theory and game theoretic analysis.

Implications: Findings from this project will provide decision makers with a holistic understanding of potential impact of these regulations on population-level distributions and disparities in adolescent tobacco use behavior. In addition, this project will help motivate future research design and data collection, taking into consideration both inter-personal and intra-personal perspectives.
Accomplishments
Coming Soon!
View previous awardees: 2019