Evaluating New Nicotine Standards for Cigarettes

评估卷烟新尼古丁标准

• 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
• 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

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）：本中心申请的首要目标是确定卷烟尼古丁含量的显著降低如何影响当前吸烟者的烟草使用和影响。减少尼古丁含量已被提议作为一种潜在的监管措施，使香烟不上瘾，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》（FSPTCA）的通过，降低香烟中的尼古丁含量成为可能，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（但不禁止）香烟中尼古丁含量的权力。拟议的赠款及其四个相互关联的项目，这些项目跨越学科界限，将有助于为政策决定提供信息。项目1包括两项人体研究，评估尼古丁产量在被认为处于或低于依赖阈值的范围内的剂量-反应关系，以及同时使用尼古丁替代疗法（NRT）促进向VLNC香烟过渡的可能性。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，并比较立即转换为VLNC香烟与在20周内逐渐降低香烟中尼古丁含量。项目3开始解决一个重要的问题，即尼古丁含量新标准在亚人群（这里我们重点关注精神分裂症吸烟者）中的可行性，这些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值剂量与微量生物碱、β-咔啉、乙醛和MAO抑制剂的存在之间的关系，解决了烟草中其他成分的操纵可能抵消VLNC香烟的预期增益的问题。这个项目对整个中心的贡献是至关重要的。为了实现这些目标，我们提出了一个管理核心（核心A），一个生物标志物核心（核心B）和一个生物统计学核心（核心C）。