The overarching goal of this application is to establish a Vermont Center on Tobacco Regulatory Science (VCTRS). This multidisciplinary center will be located at the University of Vermont but w/ill work closely with collaborators and consultants from Brown University, Johns Hopkins University, University of Minnesota, and University of Pittsburgh. The VCTRS will address one of the crosscutting and two of the specific research priorities of the Food and Drug Administration (FDA) Center for Tobacco Products. The crosscutting priority will be researching tobacco products in vulnerable populations, including women of childbearing age/pregnant women, individuals with comorbid other substance use disorders, and individuals with comorbid serious mental illness. Each of these populations is at increased risk for tobacco use and dependence or tobacco-related adverse health outcomes. Yet despite these serious vulnerabilities, these populations are typically excluded from tobacco regulatory studies. For the FDA to effectively execute its tobacco regulatory responsibilities, having sound scientific evidence on how new tobacco products impact vulnerable populations is critically important. Our goal is for the VCTRS to assist in providing the FDA with that evidence. Regarding specific priorities, the VCTRS will research (a) reducing the addiction potential of cigarettes and other tobacco products by reducing their nicotine content and (b) examining the impact of new products on biomarkers of exposure and health outcomes in vulnerable populations. Regulating the nicotine content of cigarettes and other products is an important responsibility of the FDA that has tremendous potential to reduce smoking prevalence and improve the U.S. public health. The VCTRS will be organized around four primary aims. First, we will establish an Administrative Core that will provide the leadership, administrative and intellectual infrastructure, and organizational oversight necessary to develop and sustain a multidisciplinary center of research and training excellence. Second, we will complete three multi-site research projects evaluating the effects of very low nicotine content (VLNC) cigarettes in vulnerable populations. Third, we will establish a program to support developmental studies in tobacco regulatory science and respond to time-sensitive research priorities. Fourth, we will develop an exemplary predoctoral and postdoctoral training program in tobacco regulatory science. Overall, this proposal has the potential to establish a multidisciplinary center capable o providing the FDA with critically important empirical evidence relevant to its regulatory responsibilities, while also contributing new scientific knowledge on reducing the addictiveness of tobacco products and associated adverse health consequences in vulnerable populations.
Those individuals who are most vulnerable to the addictive properties and adverse health outcomes of tobacco use are also frequently the least studied, often specifically excluded from tobacco research studies. The proposed Vermont Center of Tobacco Regulatory Science would specifically investigate the health and behavioral impacts of the use of new tobacco products in these vulnerable populations.
|Cepeda-Benito, A; Doogan, N J; Redner, R et al. (2018) Trend differences in men and women in rural and urban U.S. settings. Prev Med 117:69-75|
|D'Alberto, Nicholas; Chaarani, Bader; Orr, Catherine A et al. (2018) Individual differences in stop-related activity are inflated by the adaptive algorithm in the stop signal task. Hum Brain Mapp 39:3263-3276|
|Gaalema, Diann E; Leventhal, Adam M; Priest, Jeffrey S et al. (2018) Understanding individual differences in vulnerability to cigarette smoking is enhanced by attention to the intersection of common risk factors. Prev Med 117:38-42|
|Ganz, Ollie; Johnson, Amanda L; Cohn, Amy M et al. (2018) Tobacco harm perceptions and use among sexual and gender minorities: findings from a national sample of young adults in the United States. Addict Behav 81:104-108|
|Phillips, Julie K; Skelly, Joan M; King, Sarah E et al. (2018) Associations of maternal obesity and smoking status with perinatal outcomes. J Matern Fetal Neonatal Med 31:1620-1626|
|Gaalema, Diann E; Pericot-Valverde, Irene; Bunn, Janice Y et al. (2018) Tobacco use in cardiac patients: Perceptions, use, and changes after a recent myocardial infarction among US adults in the PATH study (2013-2015). Prev Med 117:76-82|
|Lopez, Alexa A; Redner, Ryan; Kurti, Allison N et al. (2018) Tobacco and nicotine delivery product use in a U.S. national sample of women of reproductive age. Prev Med 117:61-68|
|Streck, Joanna M; Heil, Sarah H; Higgins, Stephen T et al. (2018) Tobacco withdrawal among opioid-dependent smokers. Exp Clin Psychopharmacol 26:119-124|
|Parker, Maria A; Streck, Joanna M; Bergeria, Cecilia L et al. (2018) Reduced Nicotine Content Cigarettes and Cannabis Use in Vulnerable Populations. Tob Regul Sci 4:84-91|
|Taghavi, Taraneh; Arger, Christopher A; Heil, Sarah H et al. (2018) Longitudinal Influence of Pregnancy on Nicotine Metabolic Pathways. J Pharmacol Exp Ther 364:238-245|
Showing the most recent 10 out of 74 publications