Examination of First and Second Generation E-cigarettes

第一代和第二代电子烟的检验

• 批准号: 10015208
• 负责人: Theodore Lee Wagener
• 金额: $ 53.82万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10015208
• 关键词: Adult; Biological Markers; Cigarette; DNA Damage; Data; Devices; Electronic cigarette; Enrollment; Evolution; Exposure to; Family Smoking Prevention and Tobacco Control Act; Foundations; Generations; Grant; Health; Heating; Investigation; Knowledge; Lead; Literature; Marketing; Measures; Nicotine; Nicotine Dependence; Outcome; Participant; Pattern; Physiological; Proliferating; Prospective Studies; Public Health; Randomized; Regulation; Research; Science; Smoke; Smoker; Smoking; Smoking Behavior; Smoking and Health Research; Stratification; Tobacco; Tobacco Industry; Toxicant exposure; Work; authority; base; cancer risk; carcinogenicity; cigarette smoke; cigarette smoking; cost; design; electronic cigarette use; electronic cigarette user; innovation; novel; prospective; public health relevance; tobacco products; toxicant; vapor

 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.

 描述（由适用提供）：2009年的《预防家庭吸烟和烟草控制法》授予了基于烟草产品的FDA监管机构。但是，FDA直到最近才提出了对电子烟的看法。自从他们的市场出现以来，电子烟从第一代产品（看起来像是传统的香烟）中发展起来的，几乎没有设计成分和有限的尼古丁传递到第二代产品，这些产品看起来不像传统的香烟，具有多种设计组件，并且可以实现类似民用的尼古丁 - 尼古丁级别的水平。当前文献中缺少的是一项前瞻性研究，评估了这两种主要类型的电子烟关于吸烟行为和模式，尼古丁依赖性以及有毒物质暴露和作用的生物标志物之间的差异。了解第一代电子烟对吸烟的差异影响以及代理健康成果的措施将有助于立即告知FDA施加适当产品特定产品所需的科学基础。拟议研究的总体目的是评估从常规香烟转换为第一代或第二代电子烟对吸烟行为，产品使用方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，我们将随机分配453位成年吸烟者，幼稚地使用电子烟，第一代电子烟（G1），第二代电子烟（G2）或通常的品牌香烟控制（UBC）。所有产品将持续12周。入学率仅限于未打算在未来3个月内不戒烟的吸烟者。在随机化之前，所有参与者都将在一部分时间内进行领先期，以评估正常的吸烟行为并允许对重要变量进行分层。随访时间为1、4、8、12、26和52周。我们的具体目的是1）评估G1与G2的提供对产品转换，滥用责任，吸烟数量以及感知到的尼古丁依赖性的影响； 2）评估分配给G1，G2和UBC的参与者中有害烟草成分暴露的生物标志物的变化； 3）评估分配给G1，G2和UBC的参与者中有毒作用的生物标志物的变化。这项创新的研究在其对所有电子烟设备的全面检查中以及对吸烟行为和健康成果的影响中，将为科学基金会提供FDA和其他机构需要为电子烟的制造，分销和营销建立有效的监管策略。