Project 3 Director: Andrew J. Barnes, Ph.D.

Funding Source: National Institutes of Health (NIH), National Institute of Drug Abuse (NIDA)

Project Summary: The VCU Center for the Study of Tobacco Products (CSTP) has developed a model for evaluating novel tobacco products using, as an example, electronic cigarettes (ECIGs) that heat a liquid that often contains nicotine, forming an aerosol that users inhale. The CSTP draws from several domains to assess how a potential FDA ECIG regulation might change product toxicity (Project 1) user behavior (Project 2) and addiction/abuse liability (Project 3). Also, the model will demonstrate the extent to which predictions about potential regulatory effects describe actual population-level outcomes (Project 4).

Project 3’s specific aims use standard abuse liability assessments to examine, in independent lab studies each involving exclusive ECIG users and 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:

• limits on nicotine
• constraints on nicotine flux
• reduction in flavor availability

Project 3 is informed by the Contextual Knowledge Core that ensures that independent variables reflect real-world conditions. Project directors: Dr. Caroline Cobb and Dr. Andrew Barnes

Project 3 contributes to the CSTP’s integrative theme of impact analysis that draws from the team’s abuse liability expertise to provide the FDA with tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it and generate data that show health-promoting effects are maximized and unintended consequences are minimized.

Primary Investigator: Askar Chukmaitov, M.D., Ph.D., M.P.A
Co-Investigator: Bassam Dahman, Ph.D.

Funding Source: American Cancer Society

Project Summary: This project is the first to examine a long-term impact of hospitals participating in multiple, Medicare, or Commercial ACOs on CRC quality and cost of care in the U.S. The effects of actionable structural capabilities on these outcomes will be also investigated. This study has important implications for understating how ACOs and hospital ACO participants impact cancer outcomes and treatment costs in the US. This study will also provide a needed evidence base for an ongoing national policy debate about what kinds of structural capabilities hold promise for improving cancer care delivery in the U.S. This study will provide timely evidence to providers, policy makers, payers, and other stakeholders on whether ongoing delivery and payment reforms have positive effects on cancer-related quality and cost outcomes in the U.S.

Principal Investigator: Andrew J. Barnes, Ph.D.

Funding Source: National Institute on Drug Abuse (NIDA)

Project Description: Black/African Americans (AA) have the highest tobacco-related cancer incidence and mortality rates of any racial/ethnic group. Over 70% of AA smokers smoke menthol as their usual brand, compared to 20% for White smokers. Menthol is the only characterizing flavor allowed in cigarettes under current federal regulations, and menthol use is associated with progression to established cigarette smoking as well as more difficulty quitting. Evidence regarding the effects of electronic nicotine delivery systems (ENDS, i.e., e-cigarettes) suggests these products may be a less harmful alternative to cigarettes. Little work has examined how ENDS uptake affects tobacco use and associated toxicity among AA smokers, particularly those who smoke menthol. Recently, FDA began regulating closed-system devices like JUUL, which have captured over 70% of the ENDS market and contributed to dramatic increases in youth ENDS use. As of early 2020, flavored ENDS cartridges (small, enclosed unit used as part of an ENDS) other than menthol/tobacco are banned in the US. However, to achieve its public health mission, the FDA must balance restricting access to ENDS flavors that appeal to youth with the need for evidence on “whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products” (FDA, 2018). Understanding the potential of ENDS to reduce the public health burden of combusted tobacco use equitably requires a targeted study to predict how future ENDS flavor regulations will impact AA menthol smokers. The current study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210) by performing a 3-arm, parallel-group, 6-week clinical trial of ENDS provision with follow-up to 30 days. JUUL devices with compatible cartridges at 5% nicotine, which our team has extensively evaluated, will be provided. Study arms will differ by potential FDA regulations on ENDS flavor availability: 1) the current market where only menthol and tobacco flavored ENDS cartridges are available; 2) a market where only tobacco flavor is available, and 3) a market with only unflavored cartridges. Study visits will occur weekly beginning 1 week prior to randomization with daily tobacco use monitoring throughout and biomarker/self-report data collection at each weekly visit. AA menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated ENDS. Results of this work will help FDA make predictions about the impact on AA menthol smokers of moving from the current regulatory market for cartridge-based ENDS where menthol and tobacco are available, to one where only tobacco or no flavors are available. Answers to these questions will address FDA's priorities in behavior, toxicity, and addiction, and will provide new data regarding the consequences of potential FDA regulatory actions on menthol flavor ENDS to help maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.

Principal Investigator: Andrew J. Barnes, Ph.D.

Funding Source: Virginia Foundation for Healthy Youth

Project Summary: The prevalence of current cigarette smoking among youth has declined from 2011 to 2016. In contrast, however, use of electronic cigarettes, or e-cigarettes (EC), has been increasing dramatically in recent years in the US. E-cigarettes are now the most commonly used form of tobacco among middle and high school students. In Virginia, about two in 10 high school students and one in 10 middle school students reporting EC use. In 2016, a U.S. Surgeon General’s report declared EC use among youth and young adults to be a major public health concern.

Unlike traditional cigarettes, however, EC are largely unregulated. There is an urgent need for the scientific community to provide the best available evidence to identify and address the gaps in the mandates and implementation strategies. Our study is the first that aims to use systems science and simulation modeling methods to build interactive Virginia-based tobacco prevention and control policy simulation models to assist policy development, implementation, and evaluation to prevent and control tobacco (including e-cigarettes) use among youth in Virginia.
This study will generate scientifically grounded evidence about the potential for regulations of:

• Increasing the minimum age of legal access to tobacco products (including EC)
• Imposing excise taxes on EC (and related potential increase of conventional tobacco tax)
• Creating a minimum distance for EC retail outlets from K-12 schools

The expected outcomes and deliverables include (but are not limited to): predictions of the impacts of these policy options on initiation, intensity, cessation and relapse rates of EC/combustible cigarette use across different gender, age, race/ethnicity and SES groups in Virginia; morbidity, mortality, associated saved medical expenditures and economic costs at population level; an interactive simulation platform available for policy makers and researchers to test the effects of various policy options; reports, policy briefs, and high impact peer-reviewed publications, etc.

Findings from our study will support Virginia Foundation for Healthy Youth (VFHY) in their efforts to advance legislative issues in the Commonwealth of Virginia and at the federal level, as well as inform social marketing strategies to improve the health of young people. The project proposed is highly interdisciplinary and collaborative, and the team consists of a scientific team of faculty from Virginia Commonwealth University, University of Virginia, the College of William & Mary, Georgetown University and Georgia State University, with complementary expertise. Through partnership with the Tobacco Free Alliance of Virginia, we will form a policy advisory committee that represents key youth tobacco control stakeholders in Virginia including the Virginia Community Health Care Association, the Virginia Department of Health, Virginia Department of Behavioral Health and Developmental Services, Virginia Department of Education, American Heart Association, American Lung Association and American Cancer Society. We will deliver results periodically across the three-year study, for example, semi-annually, to give policy makers access to model results during the project period as they become available. We will translate the model for VFHY, if desired, to host on its website to inform policy debates.