University of Vermont Tobacco Center of Regulatory Science

该申请的首要目标是更新佛蒙特大学烟草监管中心 科学（UVM TCORS）。这个多学科中心位于UVM，但利用密切合作， 布朗大学、约翰霍普金斯大学、匹兹堡大学和明尼苏达大学。UVM TCORS侧重于一个跨领域的综合性主题（弱势群体）和两个科学 烟草制品的食品和药物管理中心（FDA CTP）的领域（成瘾，行为）。 我们建议在现有拨款期内，以研究工作为基础， 三个弱势群体，社会经济上处于不利地位的育龄妇女/孕妇， 患有共病阿片类药物使用障碍的个体和患有共病情感障碍的个体。这一切成功都 人口的烟草使用、依赖和与烟草有关的不良健康后果的风险增加。 尽管他们的风险增加，这些人群往往被排除在烟草监管研究之外， 巨大的知识差距。UVM TCORS的总体目标是为FDA CTP提供可靠的科学依据， 烟草制品对弱势群体影响的证据，这一主题对 FDA CTP有效履行其烟草监管职责。关于具体的监管优先事项， 我们会继续致力降低经燃烧的烟草产品的尼古丁标准。我们设计了 我们在弱势群体中的研究，以配合那些在健康人群中进行的大学 匹兹堡/明尼苏达大学TCORS。本申请中提出的初步试验将检查 尼古丁的替代非燃烧来源的可用性和吸引力的程度（即，电子烟） 可能会缓和降低尼古丁标准对减少吸烟的影响。该主题将是 使用共同协议在每个主要弱势群体中进行调查， 可能的，以及有助于与上述健康人群研究进行比较的方案。 我们建议继续我们的行政和职业提升核心。行政核心 在过去4年中，支持完成了3项多中心研究，另外3项研究正在进行中，沿着 许多试点/发展研究。这些项目累计在同行中发表了58篇出版物， 在国家科学会议上发表了更多的论文。我们提出一项计划， 有效地招募和实施试点和快速反应研究。我们建议继续进行一项高效率的 博士前和博士后指导计划，包括10名研究员的位置已连续填补 在目前的融资期内。我们将继续为FDA CTP会议和其他学术会议做出贡献。 计划继续领导弱势群体TCORS工作组，并参与 他人总的来说，UVM TCORS处于有利地位，可以成为FDA CTP和其他感兴趣的人的宝贵资产， 烟草监管科学，特别是适用于弱势群体。

The overarching goal of this application is to renew the University of Vermont Tobacco Center of Regulatory Science (UVM TCORS). This multidisciplinary center is located at UVM but leverages close collaborations with Brown University, Johns Hopkins University, University of Pittsburgh, and University of Minnesota. The UVM TCORS focuses on a crosscutting integrative theme (vulnerable populations) and two of the scientific domains (addiction, behavior) of the Food and Drug Administration Center for Tobacco Products (FDA CTP). Building programmatically on research in the current funding period, we propose to focus our primary studies on three vulnerable populations, socioeconomically disadvantaged women of reproductive age/pregnant, individuals with comorbid opioid use disorders, and individuals with comorbid affective disorders. Each of these populations is at increased risk for tobacco use, dependence, and tobacco-related adverse health outcomes. Despite their increased risk, these populations are often excluded from tobacco regulatory studies, leaving a significant knowledge gap. The overall goal of the UVM TCORS is to provide FDA CTP with sound scientific evidence on the impacts of tobacco products in vulnerable populations, a topic that is critically important to FDA CTP effectively executing its tobacco regulatory responsibilities. Regarding specific regulatory priorities, we will continue to focus on reduced nicotine standards in combusted tobacco products. We have designed our studies in vulnerable populations to align with those conducted in healthier populations by the University of Pittsburgh/University of Minnesota TCORS. The primary trials proposed in this application will examine the extent to which the availability and appeal of alternative non-combusted sources of nicotine (i.e., e-cigarettes) may moderate the impact of reduced nicotine standards on reducing cigarette smoking. That topic will be investigated in each of the primary vulnerable populations of interest using common protocols to the extent possible, and also protocols that facilitate comparisons with studies in healthier populations as noted above. We propose to continue our Administrative and Career Enhancement Cores. The Administrative Core supported completion of three multisite studies, with three others underway, during the past 4 years, along with numerous pilot/developmental studies. Cumulatively, those projects resulted in 58 publications in peer- reviewed journals and many more presentations at national scientific meetings. We are proposing a plan to effectively recruit and implement pilot and rapid-response studies. We propose to continue a highly effective predoctoral and postdoctoral mentoring program comprising 10 fellow slots that have been continuously filled during the current funding period. We will continue contributing to FDA CTP conferences and other scholarly initiatives, and plan to continue leading the Vulnerable Populations TCORS Workgroup and to participate in others. Overall, UVM TCORS is well positioned to be a valuable asset to FDA CTP and others with interests in tobacco regulatory science especially as it applies to vulnerable populations.