Evaluating New Nicotine Standards for Cigarettes

评估卷烟新尼古丁标准

基本信息

批准号：
8710130
负责人：
ERIC Christian DONNY
金额：
$ 1404.62万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8710130
关键词：
Acetaldehyde Address Administrator Affect Alkaloids Area Automobile Driving Beta Carbolines Biological Markers Biostatistics Core Characteristics Cigarette Collaborations Communication Communities Computer Simulation Congresses Data Data Collection Dependence Dose Ensure Epidemiology Exposure to Family Smoking Prevention and Tobacco Control Act Functional disorder Goals Grant Health Health behavior Housing Human Laws Leadership Maintenance Measures Methods Minor Monoamine Oxidase Inhibitors Morbidity - disease rate Neurosciences Nicotine Outcome Perception Pharmacology and Toxicology Pilot Projects Policies Policy Maker Population Prevalence Principal Investigator Process Provider Psychiatry Psychological reinforcement Psychology Public Health Rattus Recommendation Regulation Research Research Infrastructure Research Personnel Sampling Schizophrenia Science Scientist Self Administration Smoke Smoker Smoking TNFRSF5 gene Tobacco Translating Translational Research Translations United States Food and Drug Administration Universities authority data management evidence base improved meetings mortality multi-site trial nicotine replacement response

项目摘要

DESCRIPTION (provided by applicant): The overarching goal of this center application is to determine how marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers. Reduction in nicotine content has been proposed as a potential regulatory measure to render cigarettes non-addictive and, consequently, to reduce smoke exposure and improve public health. Reducing nicotine content in cigarettes has become a possibility as a result of the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the Food and Drug Administration jurisdiction over tobacco products including the authority to reduce (but not ban) levels of nicotine in cigarettes. The proposed grant with its four inter-related projects, which cross disciplinary boundaries, will help to inform policy decisions. Project 1 includes two human studies evaluating the dose-response relationship for nicotine yield within the range thought to be at or below threshold for dependence and the potential use of concurrent nicotine replacement therapy (NRT) to facilitate the transition to VLNC cigarettes. Project 2 is a multi-site trial assessing the effects of prolonged use of VLNC in a large sample and comparing immediately switching to VLNC cigarettes to gradually reducing the nicotine content in cigarettes over a period of 20 weeks. Project 3 begins to address an important concern about the viability of a new standard for nicotine content in sub-populations (here we focus on smokers with schizophrenia) who might be particularly vulnerable to the effects of reduction in nicotine. Project 4 addresses concerns that the manipulation of other constituents in tobacco could offset the predicted gains of VLNC cigarettes by determining the relationship between the threshold dose for maintaining rat nicotine self-administration and the presence of minor alkaloids, beta-carbolines, acetaldehyde, and MAO inhibitors. The contribution of this Project to the overall center is Crucial. To accomplish these goals, we have proposed an Administrative Core (Core A), a Biomarkers Core (Core B), and a Biostatistics Core (Core C).

描述（由申请人提供）：该中心申请的总体目标是确定香烟尼古丁含量的显着降低如何影响当前吸烟者的烟草使用和效果。减少尼古丁含量已被提议作为一项潜在的监管措施，使香烟不成瘾，从而减少烟雾暴露并改善公众健康。由于《家庭吸烟预防和烟草控制法案》(FSPTCA) 的通过，减少香烟中的尼古丁含量已成为可能，该法案赋予食品和药物管理局对烟草产品的管辖权，包括降低（但不是禁止）尼古丁含量的权力香烟中的尼古丁。拟议的赠款及其四个相互关联的项目跨越学科界限，将有助于为政策决策提供信息。项目 1 包括两项人体研究，评估尼古丁产量在被认为等于或低于依赖阈值的范围内的剂量反应关系，以及同时尼古丁替代疗法 (NRT) 的潜在用途，以促进向 VLNC 卷烟的过渡。项目 2 是一项多中心试验，在大样本中评估长期使用 VLNC 的影响，并比较立即改用 VLNC 卷烟与在 20 周内逐渐降低卷烟中的尼古丁含量。项目 3 开始解决一个重要问题，即尼古丁含量新标准在亚人群（这里我们重点关注患有精神分裂症的吸烟者）中的可行性，这些亚人群可能特别容易受到尼古丁减少的影响。项目 4 通过确定维持大鼠尼古丁自我给药的阈剂量与微量生物碱、β-咔啉、乙醛和 MAO 的存在之间的关系，解决了对烟草中其他成分的操纵可能抵消 VLNC 卷烟的预期收益的担忧抑制剂。该项目对整个中心的贡献至关重要。为了实现这些目标，我们提出了管理核心（核心 A）、生物标记核心（核心 B）和生物统计核心（核心 C）。