Effects of cigar flavors on measures of abuse liability among young adults

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

Funding Source: National Institutes on Drug Abuse

Project Summary:

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.

Delivering High-Quality HIV Care in the South: System-Level Policy Alternatives

Principal Investigator: April D. Kimmel, Ph.D.

Funding Source: National Institute on Minority Health and Health Disparities

Project Summary:

While clinical care for HIV has made tremendous advances, the majority of persons living with HIV in the US do not receive the evidence-based care that will allow them to fully extend life and improve health. Lack of effective HIV care is particularly problematic in the Southern region, the epicenter of the US HIV epidemic and where poverty, uninsurance, rurality, and a constrained health workforce further threaten effective care. Research suggests that system-level factors, or the structural and policy-related aspects of health care delivery, have the potential to improve quality of care and health outcomes. But little is known about their role in the context of HIV care delivery, quality of care, and health outcomes. The proposed research will study how two modifiable system-level factors—geographic accessibility to care and physician payment policies—affect quality of HIV care and population outcomes, including new HIV infections, along the HIV care continuum in the US South. Because racial and ethnic minorities face increased barriers to HIV care, we pay special attention to how these system-level factors may contribute to disparities in quality of HIV care and population outcomes along the HIV care continuum. The research involves developing a novel database that combines multiple data sources, including Medicaid administrative claims files, HIV surveillance data, and county and state characteristics from national datasets. Our approach will rely on state-of-the-art spatial network analysis and data visualization (mapping), statistical tests using econometric methods, and systems science forecasting techniques that have been used to study quality of care and population health outcomes. The work moves beyond examination of core quality of HIV care measures to include HIV-related preventive care measures that collectively are critical to reducing HIV morbidity and mortality. In investigating these factors, the study will answer a number of important questions. How do geographic accessibility, measured in travel time to receive care, and physician payment for services affect quality of HIV care in the South? Are these effects different among racial and ethnic minorities? Do improvements in geographic accessibility or increased physician payments reduce new HIV infections and racial and ethnic disparities along the HIV care continuum? The proposed study will address these questions and others. By quantifying the role of system-level factors in quality of HIV care and population health along the HIV care continuum, as well as understanding disparities in these effects, the research will provide valuable information to state and federal policy makers who seek to address systemic challenges to effective HIV care, efficiently allocate scarce resources, and improve public health.

Central Africa International Epidemiologic Database to Evaluate AIDS (IeDEA)

Site Principal Investigator: April D. Kimmel, Ph.D.

Funding Source: National Institutes of Health: National Cancer Institute, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institute on Drug Abuse.

Project Summary:

Elimination of HIV infection as a cause of human illness and death, and achieving "zero HIV transmission" have been embraced by the AIDS research and treatment communities as achievable. As HIV care and treatment programs are implemented throughout Africa, critical advances in research and policy are needed, so that care and treatment resources can be deployed to optimal benefit: decreasing both new HIV transmissions and HIV-related morbidity and mortality. Among the most important challenges to maximizing the public health benefits of HIV care and treatment programs are late diagnosis of HIV-infection, low rates of linkage to care, and high rates of late ART initiation which in turn ar associated with high rates of mortality, more costly clinical management and continued HIV transmission. In addition there remain unanswered clinical questions for persons living with HIV (PLWH) even with optimal ART. For PLWH in SubSaharan Africa (SSA), ART has been highly effective in decreasing HIV-related morbidity (and mortality), but the association of HIV with metabolic diseases and other conditions of aging (e.g. cancers), and the impact of under- or over-nutrition are not well defined. Newly funded as CA-IeDEA four years ago, we have built a new Central Africa IeDEA (CA- IeDEA), and have 1.) Compiled and managed secondary source patient-level data on ~52,000 patients through both extraction from existing electronic data and new on-the-ground systems for efficient capture of clinical data in low-resource clinical settings; 2.) Been highly productive scientifically with >20 publications even while data collection was in development, and 3.) have continued to foster African leadership and build local research capacity. We propose now to increase the database modestly (to ~80,000 patients) to increase the representativeness of HIV in the region geographically and in service delivery strategies and success and to expand our implementation science approaches to optimize short- and long-term HIV care outcomes both in Central Africa and globally, continue to investigate epidemiologic questions with clinical impact, with a focus on the comorbidities of aging and women's reproductive health.

Disparities in Cancer Screening: The Role of Medicaid Policy

Site Principal Investigator: Bassam A. Dahman, Ph.D.

Funding Source: National Cancer Institute and the Office of Behavioral and Social Science Research / University of Pittsburgh

Background

There are substantial disparities in breast and cervical cancer diagnosis, treatment and outcomes in the U.S. by race, ethnicity, socio-economic and insurance status. While mortality rates have fallen over recent decades due to improved screening and treatment, these benefits are not distributed equally across the population.

Despite the existence of programs aimed at screening underserved women (e.g., the National Breast and Cervical Cancer Early Detection Program), many eligible women are not reached, and research shows that significant disparities in screening remain. Medicaid coverage for low-income women may play an important role in ensuring access to screening, though supporting evidence is limited and does not address recently enacted and proposed changes in patient eligibility, physician payment and patient cost sharing.

Study design

The study examines how existing and new policies that affect the generosity of state Medicaid programs correlate with breast and cervical cancer screening and related health outcomes among low-income women. The study will consider the effect of pre- and post-healthcare reform variation in eligibility between and within states, as well as the effect of physician payment and patient cost sharing on screening. It will also assess how the variation in Medicaid generosity across states and over time is related to outcomes including cancer incidence and stage at diagnosis.

The project brings together complementary secondary data from a number of sources. Nationally representative survey data from the Behavioral Risk Factor Surveillance System will be used to study the effects of Medicaid eligibility on breast and cervical cancer screening among low-income populations.

Medicaid administrative claims and utilization data will allow us to consider the effects of changes in eligibility as well as physician payment and patient cost sharing on screening among Medicaid enrollees. Surveillance, epidemiology and end-results cancer registry data will be used to estimate the effects of changes in Medicaid generosity on cancer incidence and stage at diagnosis.

Intended policy outcomes

Findings from this study will provide evidence about the impact of public policies on cancer screening for underserved populations. The study will be the first to explore the effects of recent Medicaid policies on breast and cervical cancer screening and diagnosis among low-income women. The outcomes considered will also serve as an indicator of the effect of health reform on prevention and women’s health.

Categorization and Effects of e-cigarette Advertising Themes on Tobacco-related Attitudes, Intentions, and Behavior among Youth

Researchers: Andrew J. Barnes, Ph.D. and Caroline Cobb, Ph.D.

Funding Source:  Virginia Foundation for Healthy Youth

Background

Electronic cigarettes, or e-cigarettes (ECs), are novel products marketed as a means for tobacco smokers to self-administer nicotine without most other tobacco toxicants. Already, 14% of the adult US population has used an EC. More worrying are the increases in youth prevalence.  A national study from December 2014 found 17% of 12th graders had used an EC in the past month (compared to 14% for cigarettes), 16% for 10th graders (vs. 7%), and 9% among 8th graders (vs. 4%).

ECs are currently unregulated at the federal level and in Virginia the only EC-related policies prohibit their sale minors and on school property. Unlike cigarettes, which have strict restrictions on advertising to youth, ECs can be marketed to youth through television, radio, magazines, and other media channels, which likely increases their appeal to this vulnerable population.

Given the evolving nature of the EC market, it is important to understand the advertising messages being put forth by the industry as well as their impact on EC attitudes, intentions, and abuse liability measures. This is particularly critical for youth, who are known to be more susceptible to advertising, and are a group of central interest to state and federal lawmakers currently considering legislation on EC advertising and the Virginia Foundation for Healthy Youth (VFHY).  

Study Design

In the current study, we will 1) qualitatively categorize current EC advertising messages into thematic categories, (e.g. themes of reduced harm compared to cigarettes, use as a cessation device, sociability, or freedom from smoking bans), 2) experimentally evaluate the receptivity of a sample of Virginia youth, 13-18 years of age (n=1,400), to the most dominant three EC advertising themes identified, and 3) compare the effects of EC message receptivity between current cigarette smokers and susceptible non-smoking youth.

Using a between-subjects design, participants will be randomized to a control condition or one of the three EC thematic conditions. Each condition will involve an EC advertising exposure and questionnaire-delivered measures. Receptivity outcomes include EC-related attitudes, intentions to use ECs, and measures of EC abuse liability using a behavioral economics-based approach (i.e., cigarette purchasing task).

Intended Policy Outcomes

To provide evidence on how potential policies regulating electronic cigarette advertising to youth will affect attitudes about and propensity to abuse alternative and traditional tobacco products.

Investigating Effects of Regulating E-Cigarette Flavoring and Modified Risk Messages on Measures of Abuse Liability

Researchers: Andrew J. Barnes, Ph.D., Caroline Cobb, Ph.D. and Thomas Eissenberg, Ph.D.

Funding Source: Massey Cancer Center Pilot Program and the CCTR Endowment Fund

Background

Tobacco use is the leading cause of preventable death worldwide and accounts for more than 480,000 deaths in the United States (US) annually. While adult smoking prevalence stagnates in the United States, new noncombustible tobacco products like electronic cigarettes (ECs) are gaining popularity. ECs are marketed as a means for tobacco smokers to self-administer nicotine without most other tobacco toxicants. An EC consists of an electric power supply (usually a battery), a heating element, and a liquid that includes propylene glycol and/or glycerin, flavorants and, usually, nicotine. ECs are currently unregulated at the federal level. In April 2014, the US Food and Drug Administration’s (FDA) Center on Tobacco Products proposed that ECs be subject to FDA regulation. The FDA’s proposal, among other things, highlighted interest in evidence to inform the regulation of EC liquid flavors and requiring approval for modified risk descriptors insinuating lower harm potential (e.g. “light,” “mild”). However, the extent to which federal oversight of EC liquid flavors and modified risk messages will affect EC use among Americans is uncertain, as is the influence of EC regulation upon combustible tobacco cigarette (CTC) use.

Study Design

This study will examine how the likelihood of abuse, or “abuse liability”, of ECs varies by EC liquid flavorings, the presence of a modified risk message, and compared to CTCs. This study will be performed among a sample of regular CTC smokers, naïve to EC, using a within subjects design: EC liquid flavor by message. Own brand CTC abuse liability will be assessed at baseline.

Intended Policy Outcomes

The evidence base established from this pilot research will be leveraged into additional funding to build and test a comprehensive set of experiments to fully characterize the effects of a broad spectrum of federal and state policies to regulate EC consumption.

RoadMaps to Health, Robert Wood Johnson Foundation Action Award

Principal Investigator: Maghboeba Mosavel, Ph.D.

Funding Source: Robert Wood Johnson Foundation, Action Award

The Petersburg Wellness Consortium (PWC) was awarded the RoadMaps to Health Action Award by the Robert Wood Johnson Foundation. The Roadmaps to Health Coaching Program offers guidance to strengthen communities’ capacity to create a culture of health for all residents. County Health Rankings & Roadmaps community coaches support community teams in selecting coaching goals, reflecting on effectiveness of current approaches, focusing strategically to get the most leverage for efforts, considering evidence informed strategies, and considering how to evaluate efforts. The PWC was established by Dr. Mosavel and her community partners in 2012 to improve Petersburg's health and wellness by optimizing resources and partnerships. It is a volunteer run organization and have been able to secure funding from various sources to address health inequities in Petersburg. The RWJ Action Awards work will accelerate or advance a Culture of Health by positioning the Petersburg Wellness Consortium to be an inclusive and sustainable umbrella organization to improve health in Petersburg. The PWC will accomplish this by building on existing and emerging assets to enhance continued efforts at improving health, working towards sustaining current partnerships and developing new partnerships with key organizations, and working towards sustainable change that focuses on systems, policies and environmental solutions. The coaching team includes the City Manager, a community activist, Dr. Mosavel as team leader, Virginia Department of Health –Crater Road District, Cameron Foundation, YMCA of Petersburg and Virginia Cooperative Extension Services.