TCORS: Pilot + Feasibility

2020 Funding Cycle Awardees

View other award years: 2022 • 2021 • 2020 • 2019

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

Abstract and accomplishments +

Abstract: Introduction: The introduction of e-cigarettes has dramatically changed the landscape of tobacco products and product-use patterns in the US. Although e-cigarettes have the potential to promote smoking cessation, their real-world impact remains uncertain. A systems approach can help to understand transitions between different patterns of tobacco and nicotine product use. Methods: The aims of this project were to leverage frequent follow-up data from the University of Wisconsin Center for Tobacco Research and Intervention’s Exhale cohort of cigarette users and dual users of cigarettes and e-cigarettes (2015-2017) to 1) determine how transition rates between cigarette and e-cigarette use depend on sociodemographic, smoking behavior, smoking dependence, and smoking biomarker measures as well as 2) time since one’s last transition. A supplementary aim was to develop a continuous spline estimator to facilitate estimation of the impact of continuous variables on transitions. In this project, we leveraged a multistate transition model, which is a type of continuous-time Markov chain model, to estimate the underlying transition hazard rates that collectively inform observed transition patterns as well as hazard ratios (HRs) comparing subgroups. Results: In this cohort, dual users were more likely to quit smoking than cigarette-only users, but the overall impact was small because most dual users returned to cigarette-only use. Moreover, e-cigarette dependence promoted continued dual use rather than smoking cessation. E-cigarette users motivated by harm or toxicity reduction or because of restrictions on where or when they could smoke had reduced rates of smoking relapse. Cigarette dependence and spousal smoking were barriers to cigarette cessation for dual users, while using e-cigarettes first in the morning, motivation to quit smoking, and sensory, social, and emotional enjoyment of e-cigarettes (secondary dependence motives) were facilitators of smoking cessation among dual users. The longer participants remained cigarette-only or dual users, the lower their propensity to transition to the other patterns of use, stabilizing around 8-12 months post-transition. Implications: Ultimately, a better understanding of the barriers and facilitators of transitions can help to develop regulations and interventions that lead to more effective use of e-cigarettes for smoking cessation.
Accomplishments: August 2022: Dr. Brouwer was co-author on an article resulting from his pilot project work. The article, published in Nicotine & Tobacco Research, is entitled “Associations of demographics, dependence, and biomarkers with transitions in tobacco product use in a cohort of cigarette users and dual users of cigarettes and e-cigarettes”.; January 2023:: This project also supported, in part, one published paper, one submitted paper, and one paper in preparation; four conference posters; several webinars and an instructional workshop; a U54 center renewal proposal; and a planned R21 proposal submission.

Title: “Modeling the Effects of E-cigarette Use on Smokers with Comorbid Major Depression”

PI: Dr. Jamie Tam, Assistant Professor at Yale University

Abstract and accomplishments +

Abstract: Introduction: Smoking rates remain unacceptably high among those with mental health conditions, including those with major depression (MD). 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: Develop a Microsimulation Model of Smoking and Major Depression (MDS).
Aim 2: 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 population, including regulations that affect the design, content, and appeal of e-cigarettes and cigarettes.
Accomplishments: July 2022: Dr. Tam’s pilot project research helped in her being awarded a K01 Grant, “Health and economic impact analysis of a reduced nicotine cigarette policy on vulnerable populations”. through the National Institute on Drug Abuse.; November 2022: During this process, I found that the parameters calibrated from the MDS compartmental model could not be directly transferred to the MDS microsimulation model. Calibration increased smoking initiation parameters while decreasing cessation parameters. It also resulted in greater age variation of depression trajectories such as recurrence and recovery. The result is a microsimulation model of smoking and major depression that will eventually be made publicly available.

Selected pilot project

Title: “Impact of prohibiting characterizing flavors in nicotine vaping products”

PI: Dr. Kai-Wen Cheng, Assistant Professor at Governors State University

Abstract and accomplishments +

Abstract: Introduction and Aims: Flavors in tobacco products have particularly strong appeal to youth and young adults. The FDA has considered banning flavors in non-cigarette tobacco products and menthol in cigarettes. This pilot grant focused on the period where several states implemented an emergency policy and prohibited flavored or non-flavored NVP sales in response to the EVALI outbreak in 2019 in the states of Washington (WA), Rhode Island (RI), and Massachusetts (MA). I used 2019 Nielsen Scanner data from Kilts Marketing Data Center Archive of the Nielsen Company at the University of Chicago Booth School of Business. I investigated the impact of a state-level NVP characterizing flavor ban on sales of restricted flavored or non-flavored NVPs. Further, I investigated potential cross-border shopping to get around sales restrictions by investigating NVP sales from the borders of surrounding states where flavored NVP sales were allowed. I contributed to the current literature by identifying NVP sales displacement due to cross-border purchase and quantifying the share of NVP sales displacement from states where sales of NVP flavors or NVPs were prohibited to states where NVP flavors or NVPs were allowed. Results: The findings indicated that flavored NVP sales declined significantly in WA, MA, and Rl after the implementation of non-flavored and/or flavored NVP sales restrictions in response to the EVALI outbreak in 2019. Potential displacements, such that individuals switched to non-restricted tobacco flavored NVPs and/or non-restricted retail channels, were identified. Findings indicated a significant increase in non-restricted tobacco flavored NVP sales after the flavor ban. Results also indicated that after WA imposed a flavor ban, weekly sales for the Washington-Oregon border area increased significantly by 69.4 (6%), 1169.7 (39%), and 2.4 (2%) (all p-values <0.01) for tobacco flavored, menthol/mint flavored, and other flavored NVPs, respectively, compared to sales in the non-border area. Similarly, after MA imposed an NVP sales ban, sales for the border areas in surrounding states, including New York, New Hampshire, Vermont, and Connecticut, increased significantly by 1637.16 (56%), 5196.78 (51%), and 276.74 (79%) (all p-values <0.01) for tobacco flavored, menthol/mint flavored, and other flavored NVPs, respectively, compared to sales for their non-border counterparts. Finally, after RI imposed its NVP flavor ban, sales from the border area in Connecticut increased significantly by 843.5 (47%), 1191.75 (16%), and 61.31 (18%) (all p-values <0.01) for tobacco flavored, menthol/mint flavored, and other flavored NVPs, respectively, compared to sales for their non-border counterparts. PUBLICATIONS: Dr. Cheng is the lead author of a manuscript resulting from her pilot project work. The paper, under preparation, is entitled “Cross State Border Nicotine Vaping Products Purchase – Early Evidence from State Emergency Sales Restrictions in 2019” with Alex Liber and David Levy.

Title: “Examine and model the impact of e-cigarette ban”

PI: Dr. Yong Yang, Assistant Professor at University of Memphis

Abstract and accomplishments +

Abstract: Introduction: Flavor bans have been under discussion for 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 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 of tobacco/e-cigarette use behavioral change in response to flavor ban policy, and tailor that knowledge to be readily used in an ABM. Aims: The study had two specific aims: (1) to assess the empirical changes in different types of e-cigarette and other tobacco use in several states that have recently implemented flavor bans; and (2) to use behavioral economic methods to estimate people’s responses to hypothetical presentations of the major different types of vaping or flavored product bans. Methods and Results: For the first aim, we conducted surveys in several states including New York, New Jersey, and Massachusetts to access the influence of various flavor ban policies. We found that despite the ban, most respondents continued to use e-cigarettes with banned flavors post-ban. Compliance of local retailers with the ban was not high, and many respondents obtained banned-flavor e-cigarettes through legal channels. For the second aim, we conducted discrete choice experiments in 2020 among adult e-cigarette users. We found that e-cigarette users prefer flavors other than tobacco and menthol, prefer open-system e-cigarettes over closed-system e-cigarettes, and prefer regular nicotine content over low nicotine content. Preferences varied by demographics, by the primarily used device and flavor of e-cigarettes, and by smoking status. When other flavors were banned from open-system e-cigarettes participants tended to switch to menthol flavor. The preference difference among products/devices is larger than the differences between flavors and nicotine content. People tend to switch from closed-system to open-system rather than vice versa. Heated tobacco products (HTP), as a relatively new product, were less preferred compared for both cigarettes and e-cigarettes in general.
Accomplishments: JULY 22, 2021: Dr. Yang was lead author of an article resulting in part from his pilot project work. The article, published in Tobacco Control, is entitled “Impact of Flavours, Device, Nicotine Levels and Price on Adult E-cigarette Users’ Tobacco and Nicotine Product Choices”.; MARCH 30, 2022: Dr. Yang was the lead author of an article resulting from his pilot project work. The article, published in Nicotine & Tobacco Research, is entitled “How Smokers of Menthol Cigarettes and Flavored Cigars Might Respond to FDA’s Proposed Bans”.; NOVEMBER 29, 2022: Dr. Yang was lead author of an article resulting in part from his pilot project work. The article, published in Tobacco Control, is entitled “Should menthol e-cigarettes be banned? Reaction of adult smokers and users of e-cigarettes to hypothetical bans.”; JANUARY 31, 2023: Dr. Yang was lead author of an article resulting in part from his pilot project work. The article, published in Translational Behavioral Medicine, is entitled “Reactions to hypothetical flavor bans among current users of flavored e-cigarettes.”

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

Abstract and accomplishments +

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 in this population. 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: This study aimed to identify: 1) the actions of ENDS salt-base nicotine users when their ENDS device increases in price and 2) if menthol cigarettes are stronger substitutes than non-menthol cigarettes. Methods: Participants (n=9) were endowed with an account balance based on their baseline intake of tobacco products for use in an online purchasing analog called the Experimental Tobacco Marketplace (ETM). The ETM included a variety of tobacco products, including menthol and non-menthol cigarettes, available for purchase at constant prices while the price of the participants’ ENDS product increased (¼ market price (MP), ½ MP, MP, 2X MP, and 4X MP). Results: All participants have been salt-based young adult users of ENDS. Preliminary ETM findings with nine participants show a decrease in purchasing of their ENDS product as price increased. Their average number of ENDS product purchases were 3.1 at ¼ MP, 1.5 at ½ MP, 1.5 at MP, 1 at 2X MP, and 0.5 at 4X MP. They, however, did not choose to substitute with cigarettes, either menthol or non-menthol. Only three of the participants selected any alternative products no matter the price of their ENDS product. One of those participants chose to substitute with IQOS smooth menthol heat sticks at 2X and 4X the MP for their ENDS product, another chose to substitute smooth menthol and tobacco IQOS at ½ - 2X MP, and the third chose to substitute On! mint flavor at 4X market price for their ENDS product. These substitution results could suggest that the menthol and mint flavoring is an appealing factor related to choice of alternative tobacco products among current users. Results should be interpreted cautiously given that only nine participants have completed the study. Recruitment is ongoing.

Title: “Identifying Causal Pathways in Longitudinal Tobacco Product Transition Studies”

PI: Dr. Shu Xu, Clinical Assistant Professor at New York University

Abstract and accomplishments +

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 was to apply and disseminate causal mediation methods to tobacco research. Specifically, we applied 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: The data for the study were from the Population Assessment of Tobacco Research (PATH) study Waves 1 - 4. We conducted mediation analyses using data from the 7511 youth who initiated e-cigarette use or remained tobacco naive at Wave 2, reported harm perceptions of e-cigarette use at Wave 3, and reported current tobacco use at Wave 4. All potential confounders (e.g., demographics, drug use history, perception of harm) were reported at Wave 1. Results: Among the 7.3% (n = 546) of youth who initiated e-cigarette use at Wave 2, 47.4% (n = 259) perceived e-cigarette use as less harmful than cigarette use at Wave 3, and 33.7% (n = 184) became current tobacco users at Wave 4. Among the 92.7% (n = 6965) of youth who did not initiate e-cigarette use at Wave 2, 27.5% (n = 1912) perceived e-cigarette use as less harmful than cigarette use at Wave 3, and 9.4% (n = 654) became current tobacco users at Wave 4 (reported past-30-day use of any tobacco products including e-cigarettes, traditional cigarettes, cigar, chewing tobacco/snuff/dip, hookah, roll-your-own cigarette, pipe, snus, dissolvable, bidi, or heated tobacco). We used three estimation methods, the traditional mediation analysis, and two causal mediation analyses using resampling and weighting methods, to adjust for confounding in the causal pathways. The results of the three methods consistently indicated that e-cigarette initiation is causally associated with perception of e-cigarette as less harmful relative to cigarette use, which leads to subsequent current tobacco product use.
Accomplishments: OCTOBER 31, 2021: Dr. Xu was the lead author of an article resulting from her pilot project work. The article, published in Prevention Science, is entitled “Relationships Between E-cigarette Use and Subsequent Cigarette Initiation Among Adolescents in the PATH Study: an Entropy Balancing Propensity Score Analysis”.; APRIL 2023: Dr. Xu’s pilot project research and participation in a CAsToR grant proposal workshop helped her to shape a K01 proposal, “Using causal machine learning methods to inform tobacco regulatory science,” which was awarded through the National Institute on Drug Abuse.; JULY 2023: Dr. Xu was the lead author of an article resulting in part from her pilot project work. The article, published in Health Psychology, is entitled “Tutorial on causal mediation analysis with binary variables: An application to health psychology research”.

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

Abstract and accomplishments +

Abstract: Introduction: The availability of flavors 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: This study examined the toxicity of DIY flavored ECIG liquids, specifically: 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: DIY liquid additives were identified by reviewing ECIG users’ reported responses to a hypothetical flavor ban and a review of 15 ECIG internet forums to include essential oils, cannabidiol oil (CBD), sucralose, ethyl maltol. Concentrations of additives and PG/VG ratio were based on popular recipes identified in ECIG forums or DIY websites. A total of 27 liquids containing different levels and combinations of sucralose, CBD, essential oil, nicotine, and tobacco and menthol flavors were prepared. These liquids were used to assess reactive oxygen species (ROS) emissions in machine-generated aerosols. DIY flavor concentrates and commercially available flavored liquids were tested for comparison. Results: Data showed that aerosols generated from DIY flavor concentrates or from menthol and tobacco flavors mixed with DIY additives yielded similar ROS levels compared to commercially available flavored liquids. Moreover, mixing menthol flavor with CBD or essential oil yielded significantly higher ROS emissions than menthol or PG/VG liquid. Only CBD yielded significantly higher ROS with tobacco flavor. Varying sucralose concentration in the liquid yielded the same levels of ROS as PG/VG base liquid. However, increasing power within the same concentration condition yielded significantly higher ROS. Interestingly, nicotine form affected ROS emissions from a liquid containing sucralose. Implications: Our data showed that DIY liquids may be as toxic as commercially available flavored ECIG liquids. Restricting flavor availability while keeping DIY concentrates and DIY additives available for ECIG users reduces the impact of the introduced policy.
Accomplishments: November 2022: Drs. El-Hellani and Soule were first and second authors of an article resulting from their pilot project work. The article, published in Tobacco Control, is entitled “Assessing toxicant emissions from e-liquids with DIY additives used in response to a potential flavour ban in e-cigarettes”.

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

Abstract and accomplishments +

Abstract: Introduction: Several existing tobacco product regulatory actions and changes in tobacco product characteristics, such as required warning messages displayed 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 populations and persisting disparities among the socially disadvantaged. Extensive evidence has shown that social networks have a significant impact on information diffusion and behavioral choices, which are key determinants of long-term effectiveness of tobacco product regulations. Results and Implications: Using agent-based computational experiments, this project incorporated individual decision making and opinion dynamics over social networks into a social learning model to evaluate how individual decision making and diffusion over social networks collectively affect tobacco product regulation effectiveness. Findings from this project suggested that individual decision making and social network structural characteristics are both critical to the long-term effectiveness of tobacco product regulations. Ensuring communities’ openness to adopt novel opinions alone can lead to reduced prevalence of harmful behaviors. When taking into consideration the presence of social networks, the presence of a highly clustered network does not imply more necessity or higher effectiveness of tobacco product regulations as a result of network-based diffusion. Paradoxically, in more scattered networks with longer average path length, regulatory actions targeting individual incentives may be more effective. Findings from our model highlighted the importance of individual inertia in decision making in shaping the outcomes of tobacco product regulations.

View other award years: 2022 • 2021 • 2020 • 2019