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

描述(申请人提供)：在美国成人吸烟率停滞不前的同时，像电子烟(电子烟)这样的新型不可燃烟草产品正在变得越来越流行。事实上，烟草行业(奥驰亚、罗瑞拉德和雷诺美国公司)和电子烟制造商(NJOY)最近的报告证实了对这些产品的积极承诺，国家对电子烟普及率的估计反映了人们对电子烟认识和使用的转变。分析实验室的数据表明，电子烟的尼古丁液体和相关的气雾剂含有不同数量的尼古丁，与烟草香烟相比，致癌物质的水平非常低。电子烟的急性临床研究表明，在某些条件下尼古丁有显著的释放，并且没有一氧化碳(CO)暴露。目前尚不清楚电子烟如何影响烟草使用行为和毒物暴露，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接触产品(“PREP”)的模型，以检查电子烟如何影响吸烟者的潜在危害措施。目前香烟和电子烟的双重使用者(N=28)将完成4个为期5天的条件，这些条件因临时使用的烟草产品而不同：1)香烟和电子烟(双重用途)，2)仅吸烟，3)仅电子烟，以及4)不吸烟/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。烟草产品消费量将使用实物产品计数和日常监测进行评估，毒物暴露将通过一氧化碳、尿可替宁以及烟草特有的亚硝胺和潜在的肺癌致癌物NNK(总NNAL)的两个尿代谢物的总和每周三次进行测量。来自双重产品使用条件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。所有情况下的数据将被用来评估与单一产品使用和不使用烟草/尼古丁相比，双重使用期间毒物暴露的变化。二次分析包括评估与香烟和电子烟双重使用有关的心血管和主观影响，并确定5天内双重使用模式的特征。这个探索性的R21项目的结果将解决与单一产品相比，香烟和电子烟的双重使用是否会减少、对潜在危害的影响很小或增加措施 使用和不使用烟草/尼古丁。鉴于这一领域以往文献的缺乏以及电子烟普及率和产品推广的日益增加，这项研究将是烟草产品中心审议如何最好地规范现有和新电子烟产品的批准和营销的关键。该项目还将帮助制定未来的R01赠款申请，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。

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.