Principal Investigator: Andrew J. Barnes, Ph.D.
Funding Source: National Cancer Institute Grant No. 1UG1CA189869-01
Massey Cancer Center (MCC) will serve as the primary component site for an NCORP Minority/Underserved Community Site award in partnership with nine collaborating community component sites. The overall objectives of this partnership are to extend novel, innovative, and effective minority recruitment approaches to an expanded base of community component sites, increase opportunities for minority and medically underserved individuals to participate in Cancer Clinical Trial Research (CCTR), and to integrate Cancer Care Delivery Research (CCDR) into the overall MB-NCORP. Accordingly, the specific aims of this proposal are to (1) establish a research infrastructure that will further enable community component sites to conduct CCTR with an emphasis on trials relevant to minority and medically underserved populations, (2) conduct NCI-approved CCTR at the MCC primary component site and throughout the community component sites, and (3) integrate Cancer Care Delivery Research (CCDR) into the overall MB-NCORP.
The research design of the MB-NCORP offers a full menu of cancer studies including those in cancer prevention and control, screening, treatment, imaging, and CCDR. The proposed research is relevant to the mission of the NCI as MCC and the community component sites will bring cancer clinical trials and research to low-income, minority, and medically underserved individuals who otherwise would not have access to such studies. These studies will address many diverse factors from patient, provider, organizational, and policy perspectives that contribute to known disparities in cancer detection, treatment, and outcomes. Targeting the minority/underserved populations in their communities is a critical step toward alleviating the cancer care disparities prevalent in these populations.
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.
Funding Source: Virginia Foundation for Healthy Youth
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).
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).
Funding Source: Massey Cancer Center Pilot Program and the CCTR Endowment Fund
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.
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.