Site Principal Investigator: Andrew Barnes, Ph.D.
Funding Source: University of Pittsburgh/NIDA
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 9 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
Project 3 Director: Andrew Barnes, Ph.D.
Funding Source: NIH/NIDA
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: (1) limits on nicotine, (2) constraints on nicotine flux and (3) 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.
Principal Investigator: Andrew J. Barnes, Ph.D.
Funding Source: National Institutes on Drug Abuse
Tobacco use contributes to nearly half a million deaths in the United States annually. To reduce this death toll, the Food and Drug Administration (FDA) was granted regulatory authority over tobacco in 2009. This authority was limited with respect to cigars, which are increasingly popular. In 2014, FDA proposed broader regulatory control over these products, including flavored cigars. The availability of cigar flavors, among other characteristics, has been linked to increased sales and consumption, with the largest increases among youth/young adults and certain racial/ethnic minorities. No studies exist quantifying the effect of cigar flavors on abuse liability—the degree to which a psychoactive drug or formulation would be used for nonmedical purposes and that abuse would lead to dependence. Such evidence is essential to reducing cigar smoking among youth/young adults, who have a high risk of experimentation and relevance to FDA priorities. The current study aims to address this critical evidence gap by systematically examining the effect of four flavors of Black & Mild (B&M), the most popular cigar brand, on three measures of abuse liability in young adult conventional tobacco cigarette (CTC) smokers: 1) exposure to nicotine via saliva concentrations; 2) breakpoint from behavioral tasks where individuals choose between money or cigar puffs; 3) and subjective measures of cigar effects. Current CTC smokers (N=25; aged 18-21 years), who are inexperienced cigar smokers (≤5 times), will complete 5 Latin-square ordered, within-subject laboratory conditions that differ by product smoked: own brand CTC or B&M cigars in original, apple, cream, or wine flavor. The proposed study closely aligns with FDA-CTP priorities articulated in RFA-OD-15-004 including cigar initiation, use (and multiple use), perceptions, dependence and toxicity and the impact of tobacco product characteristics on initiation among populations most at-risk for flavored tobacco use. Results from this work will inform the impending regulation of cigars specifically as well as provide a method that can be used to evaluate the influence of flavors in other tobacco products. We will leverage the evidence base established from this research into a R01 proposal to test a broad spectrum of policies to regulate tobacco product flavors.
Principal Investigator: Andrew J. Barnes, Ph.D.
Funding Source: VFHY
Abstract:This one-year mixed methods study combines best practices from multiple methodologies to examine three interrelated research domains: 1) self-reported and objective tobacco-related health measures (spirometry) and biomarkers (salivary cotinine and c-reactive protein), 2) tobacco-related attitudes, perceptions, knowledge, and behaviors, and (3) tobacco-policy/prevention relevant environmental factors (tobacco advertising exposures, tobacco purchase availability) among a sample of cigar smoking and non-tobacco-using youth residing in low SES communities near Richmond, VA. Importantly, individual level results from spirometry tests will be shared with participants as a part of the research process, providing an immediate benefit to participants in addition to likely long-term societal benefits. Recruited participants aged 13-17 years meeting either past 30-day cigar use (N=100) or non-user (N=100) inclusion criteria will complete a single in-person session to collect biomarker and health measures, assess other quantitative data outcomes via a survey, and indicate whether they would like to be re-contacted for future focus groups. Focus groups stratified by past 30-day tobacco use status (N~4; 6-10 individuals per group) will begin at the mid-way point of quantitative data collection and will be used to elucidate and expand upon results from domains 1-3 to provide greater context and meaning of health/biological measures, tobacco-related attitudes, perceptions, knowledge, and behavior, and tobacco-related environmental factors. The proposed approach will provide an in-depth physiological, psychological, and behavioral characterization of youth at risk for negative health outcomes associated with cigar use that can be used to inform prevention and policy efforts among youth living in low SES communities. Study aims are consistent with the VFHY’s mission and goals related to youth tobacco use prevention and specifically aligned with several priorities described in the current RFP: to investigate 1) knowledge, perceptions and/or impact of new and/or alternative tobacco products including flavored products on youth in Virginia, 2) methods to discourage experimentation/initiation of use of alternative tobacco products, 3) the effect of policies and the retail environment on youth initiation, prevalence and/or poly-use, and 4) disparities among differing groups of youth based on social determinants of health. Such evidence will provide the foundation for future studies to define the long-term impact of cigar products on the health of vulnerable populations as well as guide policies to rebalance tobacco policy/prevention efforts to improve health equity. The combination of a well-designed and concise study timeline and team experienced in community-engaged research will ensure the availability of results that can make an impact within local communities and Virginia at large to improve outcomes related to youth tobacco use.