UK awarded $19 million to research tobacco regulation in Appalachia, inform FDA

The University of Kentucky will be home to a new research center focused on tobacco regulations in the Commonwealth named the Appalachian Tobacco Regulatory Science Team (AppalTRuST).

AppalTRuST is funded over five years with a $19 million grant from the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH), the Office of the Director of the NIH and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP). As part of an interagency partnership, the NIH and FDA award Tobacco Centers of Regulatory Science (TCORS) grants that support studies across topics like toxicity, addiction, health effects and marketing.

The goal of AppalTRuST is to investigate the impact of federal regulatory policies in rural communities through collaboration, education and pioneering regulatory scientific research.

“When I look at the landscape of Kentucky, I’m confronted with the evidence that this is a state with its own struggles and health disparities associated with tobacco use, particularly in Appalachian Kentucky,” said Seth Himelhoch, M.D., chair of the Department of Psychiatry in the UK College of Medicine and principal investigator of the award. “While America has overall reduced its use of combustible tobacco, Appalachian Kentucky, in particular, has not moved along at the same pace.”

Historically, Kentucky has had high rates of tobacco use and continues to hold one of the highest smoking rates among adults — 19.6% in 2021 according to the Centers for Disease Control and Prevention (CDC).

“It seems very important to me that when the federal government is going to evaluate regulations for tobacco use it should certainly be doing so in a part of the country where decreasing combustible tobacco use is likely to lead to long-term health benefits including reductions in cancer and cardiovascular disease,” said Himelhoch.  

“Tobacco has long been an issue that challenges the health and well-being of Kentucky. It is our mission as scientists and stewards of our land-grant institution to advance the Commonwealth beyond any obstacles to its public health,” said Vice President for Research Lisa Cassis. “This award offers the team behind AppalTRuST an opportunity to lay a foundation for high-level, innovative and interdisciplinary research to make an impact on our state.”

Co-directing AppalTRuST are Ellen J. Hahn, Ph.D., the Marcia A. Dake Endowed Professor in the College of Nursing, the director of the Bridging Research Efforts and Advocacy Toward Healthy Environments (BREATHE), and Teresa M. Waters, Ph.D., professor and dean of public health at Augusta University, and formerly professor and chair of health management and policy in the UK College of Public Health.  

“Kentuckians are at a much higher risk for heart disease, lung conditions and cancer due to high smoking rates and weak smoke-free protections. AppalTRuST will learn with and from the community to better understand their use of tobacco, retail marketing of tobacco projects, and consumer behaviors in rural communities,” said Hahn, a long-time scholar and advocate for tobacco prevention and cessation. “The health and economic burdens from tobacco use in our state is enormous, and we hope to foster sustainable change in our communities through this work.”

Himelhoch, Hahn and Waters are guiding a team of researchers across the colleges of Medicine, Nursing, Public Health, Education and Arts and Sciences as well as the UK Markey Cancer Center and BREATHE, who all work in the space of tobacco regulation, tobacco policy, and tobacco prevention and cessation.

AppalTRuST will focus its research in two areas of Kentucky — Boyd, Carter and Greenup counties in northeast Kentucky, on the outskirts of an urban area (Huntington, West Virginia), and a more rural group of counties in southeast Kentucky: Breathitt, Knott, Leslie, Letcher and Perry.

Himelhoch said the team is using an original research approach through a lens of rural heterogeneity, which is the idea that not all rural areas are the same and can vary significantly in terms of their features and challenges. This means that the impact of FDA regulatory policy may differ across rural areas as well.

The AppalTRuST team will begin with three separate but integrated projects to look at how people are accessing FDA-regulated tobacco products that contain nicotine and to provide an overview of the marketplace.

The first will aim to close the tobacco disparities knowledge gap by documenting tobacco use behaviors and related factors over time. The second will examine the prevalence and impact of marketing in Appalachia Kentucky along with how FDA regulations may affect patterns of use for different products.

The third project will use an Experimental Tobacco Marketplace model, which is essentially a virtual storefront, to evaluate how proposed regulations on certain products impact purchasing among adults in both studied areas of Kentucky.

AppalTRuST will have four cores to support the three research projects: Career Enhancement, Community Outreach and Participant Engagement, Bioinformatics and Analysis and the Administrative Core. Leaders stressed the importance of the Community Outreach and Participant Engagement Core which will facilitate community partnerships through community advisory boards and field staff who will recruit study participants.

“This award helps us put a formal structure in place to continue to serve the Commonwealth of Kentucky to help reduce the adverse health effects affiliated with people’s choices to use nicotine,” said Himelhoch. “AppalTRuST will lead the way and shine a light on the current problem with tobacco use and may help people find solutions to overcome those issues.”

“Much like we’ve done at the Kentucky Center on Smoke-Free Policy to provide science-based strategies and serve as a resource for our communities, we hope the findings AppalTRuST produces will provide important information to the FDA as they regulate tobacco products in a way that positively impacts the health of Kentucky’s rural communities,” said Hahn. “We are also grateful for the variety of support we received to put together this competitive grant application, including from the University of Kentucky Research Leadership Academy (RLA) and the Leveraging Clinical and Behavioral, Biomedical and Policy Innovations to Facilitate Tobacco Treatment in Kentucky (LIFT) Alliance.”

TCORS are the centerpiece of the Tobacco Regulatory Science Program, which implements the U.S. Department of Health and Human Services’ collaborative research effort between the NIH and FDA.

With the enactment of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA gained the authority to oversee the production, promotion and distribution of tobacco products, aiming to safeguard public health. Within the context of this legislation, the NIH and FDA collaborated to shape an all-encompassing research agenda focused on tobacco regulatory science.

Six other institutions were awarded TCORS grants including the University of North Carolina at Chapel Hill, University of Michigan, Penn State University, Ohio State University, University of South Carolina and Yale University. In total, the seven centers will receive approximately $140 million in grants from Fiscal Year 2023-2027.

Research reported in this publication was supported by NIDA and FDA Center for Tobacco Products (CTP). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.