Behavior and toxicant exposure among dual users of cigarettes and e-cigarettes

香烟和电子烟双重使用者的行为和毒物暴露

• 批准号: 8684949
• 负责人: Caroline O Cobb
• 金额: $ 21.93万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-16 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8684949
• 关键词: Acute; Address; Adult; Aerosols; Affect; Air; American; Area; Awareness; Behavior; Biological; Biological Availability; Carbon Monoxide; Carcinogens; Cardiovascular system; Categories; Cigarette; Cigarette Smoker; Clinical; Clinical Research; Consumption; Cotinine; Data; Dependence; Development; Electronics; Enrollment; Equilibrium; Exposure to; Family; Future; Grant; Health; Individual; Laboratories; Laboratory Study; Light; Liquid substance; Literature; Long-Term Effects; Lung; Manufacturer Name; Marketing; Measures; Modeling; Monitor; Nicotine; Nitrosamines; Participant; Pattern; Perception; Persons; Population; Prevalence; Public Health; Publishing; Recruitment Activity; Relative (related person); Reporting; Research; Sales; Smoke; Smokeless Tobacco; Smoker; Smoking; Sum; Techniques; Telephone; Tobacco; Tobacco Industry; Tobacco smoking; Tobacco use; Toxic effect; Toxicant exposure; United States; United States Food and Drug Administration; Visit; authority; cigarette smoking; cost; design; killings; novel; potential reduced exposure products; public health relevance; research study; smoking prevalence; tobacco control; toxicant; urinary

DESCRIPTION (provided by applicant): While adult smoking prevalence stagnates in the United States, new noncombustible tobacco products like electronic cigarettes (e-cigarettes) are gaining force. Indeed, recent reports from the tobacco industry (Altria, Lorillard, and Reynolds American) and e-cigarette manufacturers (NJOY) confirm an aggressive commitment to the sale of these products, and national estimates of e-cigarette prevalence reflect a shift in awareness and use. Data from the analytical laboratory suggest that e-cigarette nicotine liquids and associated aerosol contain variable amounts of nicotine and very low levels of carcinogens relative to tobacco cigarettes. Acute clinical studies of e-cigarettes indicate significant nicotin delivery under some conditions and no carbon monoxide (CO) exposure. It is unknown how e- cigarettes affect tobacco use behavior and toxicant exposure, particularly among those who continue to smoke cigarettes. This project adapts a previous model used to evaluate potential reduced exposure products ('PREPs') to examine how e-cigarettes affect measures of harm potential among cigarette smokers. Current dual users of cigarettes and e-cigarettes (N=28) will complete four, 5-day conditions that differ by tobacco products used ad libitum: 1) cigarette and e-cigarette (dual use), 2) cigarette-only, 3) e-cigarette-only, and 4) no tobacco/nicotine. Condition order will be assigned using a balanced Latin square design, and products will be participants' own brand cigarettes and e-cigarettes. Tobacco product consumption will be assessed using physical product counts and daily monitoring, and toxicant exposure will be measured thrice weekly via using CO, urinary cotinine, and the sum of two urinary metabolites of the tobacco-specific nitrosamine and potent lung carcinogen NNK (total NNAL). Data from the dual and single product use conditions will be used to assess changes in tobacco product consumption. Data from all conditions will be used to assess changes in toxicant exposure during dual use in comparison to single product use and no tobacco/nicotine use. Secondary analyses include evaluating cardiovascular and subjective effects associated with dual use of cigarettes and e-cigarettes and characterizing dual use patterns over a 5-day period. Results from this exploratory R21 project will address whether dual use of cigarettes and e-cigarettes decreases, has little effect on, or increases measures of harm potential relative to single product use and no tobacco/nicotine use. In light of the lack of previous literature in this area and increasing e-cigarette prevalence and product promotion, this research will be essential to inform Center for Tobacco Product deliberations on how best to regulate approval and marketing of existing and new e-cigarette products. This project will also aid the development of a future R01 grant submission related to a longer term and more detailed assessment of the effects of e-cigarette use on cigarette smoking behavior.

描述（由申请人提供）：虽然美国成人吸烟率停滞不前，但电子烟等新型不燃烟草产品正在崛起。事实上，烟草行业（奥驰亚、罗瑞拉德和雷诺美国）和电子烟制造商（NJOY）最近的报告证实了对这些产品销售的积极承诺，对电子烟流行率的国家估计反映了意识和使用的转变。来自分析实验室的数据表明，电子烟尼古丁液体和相关的气溶胶含有不同量的尼古丁，相对于烟草卷烟，致癌物水平非常低。电子烟的急性临床研究表明，在某些条件下，没有一氧化碳（CO）暴露的情况下，尼古丁的释放量很大。目前还不清楚电子烟如何影响烟草使用行为和有毒物质暴露，特别是在那些继续吸烟的人中。该项目采用了以前用于评估潜在减少暴露产品（PREP）的模型，以研究电子烟如何影响吸烟者的潜在危害措施。目前的香烟和电子烟双重使用者（N=28）将完成4个为期5天的条件，这些条件因随意使用的烟草产品而异：1）香烟和电子烟（两用），2）仅尼古丁，3）仅电子烟，4）无烟草/尼古丁。条件顺序将使用平衡的拉丁方设计分配，产品将是参与者自己的品牌香烟和电子烟。将使用物理产品计数和每日监测评估烟草产品消费，每周三次通过使用CO、尿可替宁以及烟草特异性亚硝胺和强效肺致癌物NNK的两种尿代谢产物的总和（总NNAL）测量毒物暴露。来自双重和单一产品使用条件的数据将用于评估烟草产品消费的变化。所有条件下的数据将用于评估与单一产品使用和无烟草/尼古丁使用相比，双重使用期间毒物暴露的变化。次要分析包括评估与香烟和电子烟双重使用相关的心血管和主观影响，并描述5天内的双重使用模式。这个探索性的R21项目的结果将解决香烟和电子烟的双重使用是否会减少、影响很小或增加相对于单一产品的潜在危害措施 使用和不使用烟草/尼古丁。鉴于这一领域缺乏以前的文献，以及电子烟的流行和产品推广的增加，这项研究对于烟草产品中心审议如何最好地监管现有和新电子烟产品的批准和营销至关重要。该项目还将帮助开发未来的R 01资助申请，该申请涉及对电子烟使用对吸烟行为的影响进行更长期和更详细的评估。