Examination of First and Second Generation E-cigarettes

 描述(由申请人提供)：2009年《家庭吸烟预防和烟草控制法案》授予FDA对烟草产品的监管权。然而，FDA直到最近才提出了关于电子烟的法规。自市场出现以来，电子烟已经从第一代产品演变为第二代产品，第一代产品看起来像传统香烟，设计成分很少，尼古丁释放有限；第二代产品看起来不像传统香烟，有多种设计成分，可以实现香烟一样的尼古丁释放水平。目前的文献中缺少一项前瞻性研究，该研究评估了这两种主要类型的电子烟在吸烟行为和模式、尼古丁依赖以及有毒物质暴露和影响的生物标志物方面的差异。了解第一代和第二代电子烟对吸烟的不同影响以及最近健康后果的衡量标准，将有助于立即为FDA实施适当的产品特定法规所需的科学基础提供信息。拟议研究的总体目标是评估从传统香烟转向第一代或第二代电子烟对吸烟行为、产品使用模式和持续使用的影响，以及有毒物质暴露和影响的生物标志物。为此，我们将453名成年吸烟者随机分配到第一代电子烟(G1)、第二代电子烟(G2)或普通品牌香烟对照组(UBC)。所有产品的供应期限为12周。注册将仅限于在未来3个月内不打算戒烟的吸烟者。在随机化之前，所有参与者都将参加一个导入期，以评估正常的吸烟行为，并允许对重要变量进行分层。随访将在第1、4、8、12、26和52周进行。我们的具体目标是1)评估提供G1和G2对产品转换、滥用倾向、吸烟数量和感知的尼古丁依赖的影响；2)评估分配到G1、G2和UBC的参与者中有害烟草成分暴露的生物标记物的变化；以及3)评估分配到G1、G2和UBC的参与者中毒物影响的生物标记物的变化。这项对所有电子烟设备及其对吸烟行为和健康结果的影响的创新性研究，将为FDA和其他机构为电子烟的制造、分销和营销制定有效的监管战略提供科学基础。

 DESCRIPTION (provided by applicant): The 2009 Family Smoking Prevention and Tobacco Control Act grants the FDA regulatory authority over tobacco-based products. However, the FDA only recently proposed deeming regulations on e-cigarettes. Since their market emergence, e-cigarettes have evolved from first generation products, which look like a conventional cigarette, have few design components and limited nicotine delivery, to second generation products, which do not look like conventional cigarettes, have multiple design components and can achieve cigarette-like levels of nicotine-delivery. Missing from the current literature is a prospective study assessing differences between these two major types of e-cigarettes on smoking behaviors and patterns, nicotine dependence, and on biomarkers of toxicant exposure and effect. Understanding the differential impact of first versus second generation e-cigarettes on smoking as well as measures of proximal health outcomes will help immediately inform the science base needed for the FDA to impose appropriate product specific regulations. The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a first or second generation e-cigarette on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects. To do so, we will randomly assign 453 adult smokers, naïve to e-cigarette use, to first generation e-cigarette (G1), second generation e-cigarette (G2), or usual brand cigarette control (UBC). All products will be provided for 12 weeks. Enrollment will be restricted only to smokers not planning to quit in the next 3 months. Prior to randomization, all participants will take part n a lead-in period to assess normal smoking behavior and to allow for stratification on important variables. Follow- ups will occur at 1, 4, 8, 12, 26, and 52 weeks. Our specific aims are to 1) assess the effect of provision of G1 vs. G2 on product switching, abuse liability, number of cigarettes smoked, and perceived nicotine dependence; 2) evaluate changes in biomarkers of harmful tobacco constituent exposure among participants assigned to G1, G2, and UBC; and 3) evaluate changes in biomarkers of toxicant effect among participants assigned to G1, G2, and UBC. This innovative study in its comprehensive examination of all e-cigarette devices as well as their impact on smoking behavior and health outcomes, will provide the scientific foundation the FDA and other agencies need to establish effective regulatory strategies for the manufacture, distribution, and marketing of e- cigarettes.