Continue our Administrative Core to provide the administrative and fiscal oversight and infrastructure necessary to successfully complete the proposed and FDA CTP initiated research projects, and support this vibrant multidisciplinary center of research and mentoring excellence in tobacco regulatory science.
Complete three multi-site clinical trials evaluating the effects of very low nicotine content (VLNC) cigarettes on smoking rate, dependence severity, neurobiological impacts, and toxin exposure using between subject, parallel group, research designs. Participants in each trial will be randomly assigned to 16 weeks of exposure to (1) normal nicotine content cigarettes (NNC) alone, which will serve as the control condition, (2) VLNC cigarettes alone, (3) VLNC’s + tobacco flavored nicotinized e-cigarettes (TF e-cigs), or (4) VLNC’s + nicotinized e-cigarette + preferred e-cigarette flavorings (PF e-cigs). We chose this design to be of potential direct practical utility to the FDA CTP by modeling possible market scenarios in which a reduced nicotine content policy may be implemented.
Conduct a two parallel groups, 12-week multi-site, randomized clinical trial in which pregnant women will be assigned to continue smoking their usual brand or to use a VLNC cigarette. We will assess smoking rate, dependence severity, toxin exposure, and pregnancy-specific measures. Use of noncombustibles will be recorded as a dependent variable but will not be examined as an independent variable.
Conduct pilot studies and rapid-response projects related to vulnerable populations in coordination with FDA CTP. Through our main research projects, pilot studies, and participation in TCORS workgroups during the current funding period, the UVM TCORS has developed a strong infrastructure and toolkit to be maximally responsive to FDA’s priority research areas. We will collaborate closely with FDA CTP.
Continue our Career Enhancement Core mentoring early career investigators (predoctoral and postdoctoral mentees) in tobacco regulatory science. The program will continue to be primarily located at UVM, but also include postdoctoral mentoring at our collaborating institutions, Brown University, and Johns Hopkins University. At each institution, the career enhancement program will continue to be integrated with their respective longstanding and highly regarded T32 training programs in addictions research.
CORE A- ADMINISTRATIVE CORE: The University of Vermont Tobacco Center of Regulatory Science (UVM TCORS) Administrative Core was established during the current funding period with the administrative, fiscal, and technical support staffing necessary to support a vibrant, multidisciplinary research center focused on examining the addiction potential, underpinning behavioral processes, and health impacts of using new and existing tobacco products. The Core provides fiscal management, monitors adherence to regulatory oversight, and promotes open communication and collaboration. The Core provides the intellectual infrastructure necessary to support senior and early career investigators in tobacco regulatory science, with a particular focus on investigating the potential impact of reduced nicotine standards on cigarette smoking in vulnerable populations. The Core also encourages and facilitates local, national, and international collaboration, makes effective use of the knowledge of its accomplished consultants and advisors, and nurtures interest in the importance of tobacco regulatory science for reducing smoking prevalence and tobacco-related morbidity and mortality in vulnerable populations. In the proposed funding period, the Administrative Core services will be augmented to include solicitation, review, administration and reporting for the UVM TCORS Rapid Response Projects program. Core leadership is provided by Stephen T. Higgins, PhD (Director), John R. Hughes, MD (Senior Associate Director), and Andrea C. Villanti, PhD, MPH (Associate Director of Operations). Together this Core has overseen the management of six multi-site studies and almost 30 developmental and pilot projects during the current funding period; organized and hosted 4 national conferences, with dedicated content on tobacco regulatory science; planned a 5th national conference exclusively focused on tobacco regulatory science scheduled for October of this year; edited 4 Special Issues of the peer-reviewed journal Preventive Medicine based on conference proceedings; and supported publication of 58 articles in peer-reviewed journals. The Core also provides administrative support for our successful mentoring program, which includes four predoctoral and six postdoctoral slots that were continuously filled during the current funding period. The team is well positioned to continue to provide strong management in this renewal proposal, building on the existing infrastructure for communication, coordination, and collaboration across the four proposed research projects and two cores. This infrastructure will also be leveraged to sustain and enhance existing collaboration with NIH, FDA, and other TCORS colleagues through our annual conferences, leadership in FDA workgroups, and Rapid Response Projects. Overall, we are confident that the proposed Administrative Core will allow us to sustain and enhance this center of research and mentoring excellence in tobacco regulatory science.
CORE B- CAREER ENHANCEMENT CORE: We propose to renew a Career Enhancement Core that focuses on providing predoctoral and postdoctoral fellows with high-quality research mentoring that will prepare them for careers in tobacco regulatory science research. The Core is primarily located at the University of Vermont (UVM), but also has postdoctoral fellows placed at our two collaborating sites, Brown University and Johns Hopkins University. All three institutions also have highly regarded T32 training programs in addictions research, which allows for rich cross-fertilization between tobacco regulatory science and addictions research. Consistent with the overarching focus of the UVM TCORS, this Core focuses on career enhancement around investigating use of tobacco and nicotine delivery products among vulnerable populations. The leaders of the Career Enhancement Core (Drs. Higgins and Heil) have a long history of effective collaborative mentoring in their roles as Director and Associate Director of the UVM T32 training program in addictions research. Eight additional primary mentoring faculty provide a wide range of expertise in the areas of vulnerable populations, addictions, behavioral science, and tobacco regulatory science research. Dr. Villanti bolsters our mentoring team’s expertise in tobacco regulatory science. The Career Enhancement Core provides fellows with (a) hands-on research training in tobacco regulatory science in which they directly assist faculty with implementing the primary UVM TCORS studies while simultaneously leading pilot studies, (b) opportunities to participate in an ongoing, rotating seminar series on behavioral science, behavioral economics and behavioral pharmacology, research ethics, and tobacco regulatory science, and (c) abundant opportunities to present their research at national scientific meetings and prepare articles for publication in peer-reviewed journals. During the almost 4 years of the current funding period, we have mentored 14 predoctoral and postdoctoral fellows (4 predocs and 10 postdocs). Our fellows published 29 peer-reviewed articles supported by the UVM TCORS during the current funding period, including 15 as 1st author. In the current funding period, we have used pilot projects and developmental studies to ensure that fellows gain experience with independent research, collaboration, and grant writing in tobacco regulatory science. Going forward, the Core will leverage that experience and our growing expertise in tobacco regulatory science to establish the necessary infrastructure to prepare our fellows for successful careers in tobacco regulatory science, respond effectively to FDA rapid response and other initiatives, and to nurture partnerships and collaborations within the TCORS network. Overall, we feel that this Core is well positioned to continue and enhance its mission of preparing the next generation of tobacco regulatory scientists.