Vermont Center on Tobacco Regulatory Science

佛蒙特州烟草监管科学中心

基本信息

批准号：
8915112
负责人：
Stephen T Higgins
金额：
$ 380.12万
依托单位：
UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8915112
关键词：
Address Alcohols Biological Markers Birth Carcinogen exposure Cardiovascular system Centers of Research Excellence Child Cigarette Cocaine Development Epidemic Fellowship Female of child bearing age Goals Health High Prevalence Individual Institution Interdisciplinary Study Knowledge Leadership Lung Major Depressive Disorder Measures Medical Minnesota Mothers Motivation Neurobiology Nicotine Nicotine Dependence Obesity Opiate Addiction Opioid Outcome Overweight Play Population Population Study Pregnant Women Principal Investigator Property Protocols documentation Public Health Research Research Infrastructure Research Priority Research Project Grants Research Training Risk Role Science Site Smoke Smokeless Tobacco Smoker Smoking Substance Addiction Substance Use Disorder Substance abuse problem Testing Time Tobacco Tobacco Dependence Tobacco use Training Training Programs United States Food and Drug Administration Universities Vermont Vulnerable Populations Woman Work addiction behavioral economics behavioral health cardiovascular risk factor depressive symptoms improved multidisciplinary neuroimaging post-doctoral training pre-doctoral prescription opioid programs research study response severe mental illness smoking prevalence sound

项目摘要

DESCRIPTION (provided by applicant): 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. RELEVANCE: 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.

描述（由申请人提供）：本申请的总体目标是建立佛蒙特州烟草监管科学中心 (VCTRS)。该多学科中心将设在佛蒙特大学，但将与布朗大学、约翰霍普金斯大学、明尼苏达大学和匹兹堡大学的合作者和顾问密切合作。 VCTRS 将解决美国食品和药物管理局 (FDA) 烟草制品中心的一项交叉研究重点和两项具体研究重点。交叉优先事项将是研究弱势群体的烟草产品，包括育龄妇女/孕妇、患有其他药物使用障碍的个人以及患有严重精神疾病的个人。这些人群中的每一个都面临着烟草使用和依赖或与烟草相关的不良健康后果的风险增加。然而，尽管存在这些严重的脆弱性，这些人群通常被排除在烟草监管研究之外。对于 FDA 有效履行其烟草监管职责而言，拥有关于新烟草产品如何影响弱势群体的可靠科学证据至关重要。我们的目标是让 VCTRS 协助向 FDA 提供该证据。关于具体优先事项，VCTRS 将研究 (a) 通过降低卷烟和其他烟草产品的尼古丁含量来降低其成瘾潜力，以及 (b) 检查新产品对弱势群体暴露和健康结果的生物标志物的影响。监管卷烟和其他产品的尼古丁含量是 FDA 的一项重要职责，它在降低吸烟率和改善美国公共卫生方面具有巨大潜力。 VCTRS 将围绕四个主要目标进行组织。首先，我们将建立一个行政核心，为发展和维持卓越的多学科研究和培训中心提供必要的领导、行政和智力基础设施以及组织监督。其次，我们将完成三个多地点研究项目，评估极低尼古丁含量（VLNC）香烟对弱势群体的影响。第三，我们将制定一项计划来支持烟草监管科学的发展研究并响应时间敏感的研究重点。第四，我们将制定烟草监管科学示范性博士前和博士后培养计划。总体而言，该提案有可能建立一个多学科中心，能够为 FDA 提供与其监管职责相关的极其重要的经验证据，同时还贡献新的科学知识，以减少烟草产品的成瘾性和弱势群体的相关不良健康后果。相关性：那些最容易受到烟草使用成瘾特性和不良健康后果影响的人也往往是研究最少的人，常常被明确排除在烟草研究之外。拟议的佛蒙特州烟草监管科学中心将专门调查使用新型烟草产品对这些弱势群体的健康和行为影响。