University of Vermont Tobacco Center of Regulatory Science

此应用程序的总体目标是更新佛蒙特州大学烟草监管中心 科学(UVM TCORS)。该多学科中心位于密歇根大学，但利用与 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侧重于一个横切的综合主题(弱势群体)和两个科学的 烟草制品食品和药物管理中心(FDA CTP)的领域(成瘾、行为)。 在当前资助期的研究基础上，我们计划将重点放在主要研究上 关于三个弱势群体，处于社会经济不利地位的育龄/怀孕妇女， 患有阿片类药物使用障碍的人，以及患有情感障碍的人。这其中的每一个 人口面临更高的烟草使用、依赖和与烟草相关的不良健康后果的风险。 尽管风险增加，但这些人群经常被排除在烟草监管研究之外，留下了 巨大的知识鸿沟。UVM TCORS的总体目标是为FDA CTP提供合理的科学 关于烟草产品对弱势人群影响的证据，这是一个对 FDA CTP有效地履行其烟草监管职责。关于具体的监管优先事项， 我们将继续重点降低燃烧烟草产品中的尼古丁标准。我们设计了 我们在弱势人群中的研究与加州大学在健康人群中进行的研究保持一致 匹兹堡/明尼苏达大学TCORS。本申请中建议的主要试验将检查 尼古丁的替代非燃烧来源(即电子烟)的可获得性和吸引力程度 可能会缓和降低尼古丁标准对减少吸烟的影响。这个话题将是 在每个感兴趣的主要易受伤害人群中使用共同的方案进行调查 可能的，以及如上所述便于与健康人群中的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 在过去四年中，支持完成了三项多地点研究，另外三项正在进行中，以及 大量的试点/发展研究。这些项目累计产生了58份同级出版物-- 回顾了期刊，并在国家科学会议上发表了更多的演讲。我们正在提出一项计划， 有效招募和实施试点和快速反应研究。我们建议继续进行高效的 博士后和博士后导师计划，包括10个已连续填补的研究员名额 在本供资期间。我们将继续为FDA CTP会议和其他学术活动做出贡献 倡议，并计划继续领导弱势群体TCORS工作组并参与 其他。总体而言，UVM TCORS对于FDA CTP和其他对以下领域感兴趣的公司来说是一项宝贵的资产 烟草管理科学，特别是当它适用于脆弱人群时。

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.