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.

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

Funding Source: University of Pittsburgh/National Institute on Drug Abuse (NIDA)

Project Summary: State Medicaid programs play a critical role in financing pharmacologic and non-pharmacologic treatments for opioid use disorder (OUD) as they provide coverage for 4 in 10 individuals with OUD. Efforts to improve access to high-quality OUD treatment in Medicaid have been hampered by inconsistent and incomplete measurement of quality and outcomes. States are currently taking myriad approaches to addressing the opioid crisis by changing the way they regulate providers, pay for care, and cover evidence-based treatments in Medicaid. However, there exists no analytic infrastructure for learning about the impact of state policy experimentation on OUD treatment and outcomes as states have no mechanism for sharing data or measurement tools. To overcome these challenges, we harness a Medicaid Distributed Research Network based on academic-state partnerships in Kentucky, Maryland, Michigan, North Carolina, Ohio, Pennsylvania, Virginia, West Virginia and Wisconsin. These states account for 15 million (20% of) Medicaid enrollees, and the partnerships have access to complete and recent Medicaid data.

The objectives of this application are to provide a comprehensive assessment of OUD treatment quality and outcomes in Medicaid, and to inform policy decisions on coverage and payment for evidence-based OUD treatments in Medicaid. First, we will construct and report on 15 standardized measures of OUD treatment performance in the nine states. Second, we will link Medicaid claims to vital statistics to examine the association between the quality of OUD treatment (e.g., adequate initiation, continuity, follow-up, monitoring, receipt of psychosocial care, screening) and fatal and non-fatal drug overdoses. Third, using quasi-experimental study designs, we will examine associations between Medicaid coverage policies, OUD treatment quality and overdose outcomes.

We focus on policy changes implemented recently to expand Medicaid coverage of and reduce barriers to pharmacologic treatment for OUD and to expand payment for residential treatment. Our network is uniquely positioned to disseminate our findings to state policy makers who can act on them. Our network is scalable. We will employ a robust dissemination strategy to distribute the analytic tools we develop to other states. Finally, our network is portable and can be harnessed to address not only the opioid crisis but future drug epidemics facing the US.

Principal Investigator: Peter J. Cunningham, Ph.D.

Funding Source: Virginia Department of Medical Assistance Services (DMAS)

Project Summary: The goal of the Addiction Recovery Treatment Service (ARTS) evaluation is to quantitatively and qualitatively assess the impacts of the new ARTS program.

Post-ARTS substance use disorders: The major goal of claims data analysis is to assess changes in SUD treatment access, utilization and costs at six months after implementation of the ARTS benefit.

Co-Investigator: April D. Kimmel, Ph.D.

Funding Source: Centers for Disease Control and Prevention (CDC)

Project Summary: Youth violence is a major threat to the health and wellbeing of youths in the U.S. Our project focuses on Richmond, Virginia, a medium-sized city that is ravaged by violence and poverty. In 2014, the rate of homicide among youths was nearly four times the national average. Although prevention science has shown progress in identifying promising youth violence prevention programs that focus on the individual, family or school levels, progress on community-level interventions has been scarce.

Our project involves the implementation of a community-level approach employing the Communities That Care prevention system (CTC), enhanced with the Walker-Talker (WT) community outreach program (CTC PLUS). While the CTC builds and cultivates social capital through coalition building and identification and implementation of evidence-based youth violence programs, the WT model will increase community capacity and awareness to make full use of these resources. The overall goal of this project is to implement and evaluate the community-level impact of the CTC PLUS strategy within the context of a multiple-baseline design.

Our specific objectives include:

• Determine the effectiveness of CTC PLUS on primary youth violence outcomes (e.g., youth homicides and intentional injury rates)
• Determine the extent to which CTC PLUS leads to proximal outcomes including decreased neighborhood disorganization, increased numbers of youth served by high quality, evidence-based violence prevention programs, and decreased risk and increased protective/promotive factors associated with youth violence
• Understand the impact of CTC PLUS on aspects of neighborhood and community capacity associated with youth violence prevention

Three comparable communities will be randomly assigned to receive the intervention at different implementation starting dates. The intervention will begin in the first randomly selected community (Community A), while the other two communities (Communities B and C) serve as controls. The following year, the second randomly selected community (Community B) will begin the intervention (along with the first intervention community), while the third community serves as a control. In years 4 and 5, communities A and B will continue implementing the intervention. This design will provide adequate time (3-4 years) for the intervention effect to emerge in Communities A and B. The third community (Community C) will receive training and technical support for implementing the intervention following the last wave of data collection in year 5 (representing a no-intervention control community during this funding period).

This randomization of multiple elements of the design (both the order in which the communities receive the intervention and the timing) strengthens the design considerably because it increases the number of possible assignments while maintaining the systematic staggering of the intervention introduction. This provides a basis for conducting parametric analyses and alternative analytic strategies that make fewer assumptions about the data. If proven effective, this innovative intervention will advance the science and practice of youth violence prevention and have significant public health implications.

Principal Investigator: Morgan Snell, Ph.D.

Funding Source: Virginia Department of Behavioral Health and Developmental Services (DBHDS)

Project Summary: The COVID-19 pandemic exacerbated existing challenges meeting the needs of individuals with substance use disorders (SUD) in Virginia and the nation, due to increased demand for services, barriers to accessing treatment, and SUD treatment workforce shortages. Exiting the most acute phase of the COVID-19 pandemic presents an opportunity to examine existing gaps between SUD treatment needs and supply in Virginia to inform long-term planning and increase access to services.

This project's objectives are to examine 1) trends in SUD prevalence and the need for SUD treatment services in Virginia exacerbated by the COVID-19 pandemic; (2) current capacity challenges within the SUD treatment system exacerbated by the COVID-19 pandemic; (3) regional variation in SUD treatment demand and system capacity.

Multiple Principal Investigator: Andrew Barnes, Ph.D.

Funding source: National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative, University of Pittsburgh, AcademyHealth's Evidence-Informed State Health Policy Institute

Project Summary: State Medicaid agencies play a critical role in covering OUD treatment, as more than half (54 percent) of individuals who need OUD treatment use Medicaid to pay for these expenses. Additionally, Medicaid programs disproportionately cover minoritized populations and those with socioeconomic risk factors, allowing Medicaid to reduce inequities in care. Despite past efforts of expanding the continuum of care and improving the quality of OUD care, underdeveloped OUD quality measures remain a persistent issue.  

This limitation hinders opportunities for targeted intervention and thorough evaluation of policy effects, creating a need for research and policy partnerships. MODRN EQUIP will draw on robust university-state partnerships in 12 states accounting for 24 percent of U.S. Medicaid enrollment to support efforts to improve OUD quality.  

Throughout the five years of funding, MODRN EQUIP, led by Multi-Principal Investigators Julie Donohue, Ph.D. and Andrew Barnes, Ph.D. aims to: 

1. Develop and describe provider OUD treatment quality measures that are responsive to Medicaid program and stakeholder needs. Project 1 analyzes Medicaid claims and enrollment data and engages Delaware, Kentucky, Maryland, Maine, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia, West Virginia, and Wisconsin and is led by Project Directors Marguerite Burns, Ph.D. and Evan Cole, Ph.D., M.P.H. 
2. Test case-mix approaches to enable fair comparisons across providers in OUD treatment quality measures. Project 2 utilizes Medicaid patient surveys and interviews linked with Medicaid claims and engages Michigan and Virginia, led by Project Directors Andrew Barnes, Ph.D. and Sarah Clarke, M.P.H. 
3. Quantify the contribution of patient – and provider – factors, including between and within provider effects, on provider-level OUD treatment quality and equity. Project 3 examines Electronic Health Record (EHR) data from 10 intervention clinics; Medicaid claims from intervention and comparison clinics and engages Ohio. Project 3 is led by Project Directors Dushka Crane, P.h.D., L.S.S.B.B. and Adam J. Gordon, M.D., M.P.H., F.A.C.P., D.F.A.S.A.M.

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.