University of Vermont

College of Medicine

Vermont Center on Behavior and Health

TCORS CENTER GRANT

1P50DA036114 (PI: Stephen T. Higgins)
Agency: FDA
Vermont Center on Tobacco Regulatory Sciences
09/30/13-08/31/18

 

Description

This tobacco center on regulatory science (TCORS) is one of fourteen such centers in the U.S. that are supported through a cooperative agreement of the National Institutes of Health (NIH) and Food and Drug Administration (FDA).   For the first time, the Family Smoking Prevention and Tobacco Control Act has given the federal government (i.e., FDA) the authority to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products.   This and the other TCOR centers will provide scientific expertise relevant to the FDA’s regulatory mission.

The center addresses one of the crosscutting and two of the specific research priorities of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products in carrying out its charge of regulating tobacco products.   We approach these priorities using the concepts, principles, and methods of behavioral economics and behavioral pharmacology. The center is located at the University of Vermont but works closely with collaborators and consultants from Brown University, Johns Hopkins University, University of Minnesota, and University of Pittsburgh.

The crosscutting priority is 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 VCBH to assist in providing the FDA with that evidence.

Regarding specific priorities, the VCBH will (a) investigate reducing the addiction potential of cigarettes and other tobacco products by reducing their nicotine content and (b) examine 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 VCBH TCORS project is organized around four primary aims:


First, we provide an Administrative Core that provides the leadership, administrative and intellectual infrastructure, and organizational oversight necessary to develop and sustain a multidisciplinary center of research and training excellence.

Second, we are conducting three multi-site research projects evaluating the effects of very low nicotine content (VLNC) cigarettes in vulnerable populations.

Third, we have a program to support developmental studies in tobacco regulatory science and respond to time-sensitive research priorities.

Fourth, we have a predoctoral and postdoctoral training program to develop a new generation of scientists in tobacco regulatory science.

Overall, this multidisciplinary project has been designed to provide the FDA with critically important empirical evidence on the impact of tobacco products in vulnerable populations 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.

Last modified January 27 2014 08:46 PM