Vermont Center on Tobacco Regulatory Science

佛蒙特州烟草监管科学中心

• 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
• 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

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在烟草监管科学（VCTRS）上建立佛蒙特州中心。这个多学科中心将位于佛蒙特大学，但与布朗大学，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紧密合作。 VCTR将介绍食品药品监督管理局（FDA）烟草产品中心的两个特定研究优先事项之一。横切优先级将是研究脆弱人群中的烟草产品，包括育龄/孕妇的妇女，患有其他药物使用障碍的人以及患有严重精神疾病的人。这些人群中的每一个都有增加烟草使用和依赖性或与烟草相关的不良健康结果的风险。然而，尽管这些严重的脆弱性，但这些人群通常被排除在烟草监管研究之外。为了使FDA有效地执行其烟草监管责任，就新的烟草产品如何影响弱势群体的人群有明显的科学证据至关重要。我们的目标是使VCTR协助为FDA提供该证据。关于具体的优先级，VCTR将通过减少烟碱含量来研究（a）降低香烟和其他烟草产品的成瘾潜力，以及（b）研究新产品对脆弱人群暴露和健康结果的影响。调节香烟和其他产品的尼古丁含量是FDA的重要责任，它具有降低吸烟率并改善美国公共卫生的巨大潜力。 VCTR将围绕四个主要目标组织。首先，我们将建立一个行政核心，该核心将提供领导，行政和智力基础设施以及开发和维持卓越研究和培训的多学科中心所必需的组织监督。其次，我们将完成三个多站点的研究项目，评估弱势群体中非常低的尼古丁含量（VLNC）卷烟的影响。第三，我们将建立一个计划，以支持烟草监管科学领域的发展研究并响应时间敏感的研究优先事项。第四，我们将在烟草监管科学中制定一个典范的典范和博士后培训计划。总体而言，该提案有可能建立一个能够为FDA提供与其监管责任相关的重要经验证据的能力o，同时还为减少烟草产品上瘾的成瘾性以及与脆弱人群相关的不良健康后果的新科学知识提供了新的科学知识。 相关性：那些最容易受到烟草使用的不良特性和不良健康结果的人，通常也是研究最少的人，通常是专门从烟草研究中排除的。拟议的佛蒙特州烟草监管科学中心将特别研究这些脆弱人群中新烟草产品的健康和​​行为影响。