Project 3: Using abuse liability data to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action

项目 3：使用滥用倾向数据来检验有关先进 ECIG 的假设，并生成有关潜在监管行动的人口水平预测

• 批准号: 10477273
• 负责人: Caroline O Cobb
• 金额: $ 41.34万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477273
• 关键词: Address; Aerosols; Affect; Authorization documentation; Behavior; Data; Dependence; Development; Devices; Drug usage; Electronic cigarette; Ensure; European Union; Evaluation; Exhibits; Fruit; Generations; Health Promotion; Inhalation; Intake; Knowledge; Liquid substance; Mathematics; Methods; Modeling; Nicotine; Nicotine Dependence; Pattern; Persons; Pharmaceutical Preparations; Population; Price; Publications; Regulation; Role; Testing; Time; Tobacco; Tobacco use; Toxic effect; Work; abuse liability; addiction; base; behavioral economics; cigarette user; drug-sensitive; electronic cigarette use; electronic cigarette user; indexing; liquid nicotine; novel; tobacco products; tool; willingness to pay

Project Summary. The Center for the Study of Tobacco Products (CSTP) has developed a model for evaluating novel tobacco products using, as exemplars, electronic cigarettes (ECIGs) that heat a liquid that often contains nicotine, forming an aerosol that users inhale. Now, CSTP leverages this ECIG expertise to pivot from product evaluation to an integrative theme of impact analysis. Specifically, the CSTP proposes methods with which FDA can generate predictions regarding a potential regulation’s effects and then whether or not the predicted effects occur in the population can be tested. The CSTP’s model assesses how potential regulation might influence product toxicity (Project 1), user behavior (Project 2), and product addiction/abuse liability (Project 3). In this context, Project 3 will generate new data regarding the abuse liability of advanced- generation ECIGs and will contribute, along with Projects 1 and 2, to population-level predictions. Project 4 will test those population-level predictions. FDA regulations are intended to promote health, but also may have unintended consequences. For example, limiting ECIG liquids to <20 mg/ml nicotine, as in the European Union (EU), can drive use of higher power devices that aerosolize more liquid/puff, leading users to inhale more nicotine. Unintended consequences may also occur from other actions, such as constraining ECIG nicotine flux (rate of nicotine emission), or reducing flavored ECIG liquid availability. The consequences of these and other potential regulations on ECIG use and dependence can be predicted by assessing abuse liability, or likelihood of persistent drug use/dependence. Behavioral economic tasks are validated indicators of abuse liability and reveal how much people are willing to pay for a drug, how hard they will work to earn a drug, and how sensitive they are to changes in drug prices. Project 3 specific aims use standard abuse liability assessments to examine, in independent lab studies each involving 60 exclusive ECIG users and 60 dual ECIG and tobacco cigarette users, the extent to which responding to a battery of behavioral economic tasks is influenced by three potential regulatory actions: (1) limits on nicotine, (2) constraints on nicotine flux, and (3) reduction in flavor availability. Project 3 is informed by the Contextual Knowledge Core that ensures that independent variables reflect real-world conditions. Overall, results from Project 3 will provide new data regarding ECIG abuse liability in two populations that will likely be impacted by regulatory action differently, and it also will inform testable predictions regarding the consequences of three potential regulatory actions. Project 4 examines these predictions at the population level. Thus, this project is part of a center with an integrative theme of impact analysis that draws from the team’s abuse liability expertise to provide FDA tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it, and generate data that show that its health-promoting effects are maximized and unintended consequences are minimized.

项目摘要。烟草制品研究中心（CSTP）开发了一个模型， 使用电子香烟（ECIG）作为范例评估新型烟草产品，所述电子香烟加热液体， 通常含有尼古丁，形成使用者吸入的气雾剂。现在，CSTP利用ECIG的专业知识， 从产品评估转向影响分析的综合主题。具体来说，CSTP建议 FDA可以用来预测潜在法规影响的方法， 或者预测的效应是否在群体中发生可以被检验。CSTP的模型评估了 监管可能影响产品毒性（项目1）、用户行为（项目2）和产品成瘾/滥用 责任（项目3）。在这方面，项目3将产生关于先进技术滥用责任的新数据， 这将与项目1和项目2一起沿着为人口水平的预测做出贡献。项目4将 测试这些人口水平的预测。 FDA法规旨在促进健康，但也可能产生意想不到的后果。比如说， 如欧盟（EU）那样，将ECIG液体限制为<20 mg/ml尼古丁，可以推动使用更高的功率 雾化更多液体/烟的设备，导致用户吸入更多尼古丁。意想不到的后果可能 也发生在其他行为中，如限制ECIG尼古丁通量（尼古丁排放速率），或减少 调味ECIG液体可用性。这些和其他潜在法规对ECIG使用的影响， 依赖性可以通过评估滥用倾向或持续使用药物/依赖的可能性来预测。 行为经济学任务是虐待倾向的有效指标，并揭示了人们愿意在多大程度上 他们为获得一种药物付出的努力程度，以及他们对药物价格变化的敏感程度。 项目3的具体目标是使用标准的滥用责任评估，在独立的实验室研究中， 涉及60名ECIG独家使用者和60名双重ECIG和烟草卷烟使用者， 对一系列行为经济学任务的反应受到三种潜在监管行为的影响：（1） 限制尼古丁，（2）限制尼古丁流量，和（3）减少香料的可用性。项目3被告知 通过上下文知识核心，确保独立变量反映现实世界的条件。 总体而言，项目3的结果将提供关于两个人群中ECIG滥用责任的新数据， 可能会受到监管行动的不同影响，它也将告知有关 三种潜在的监管措施。项目4在人口中检验这些预测 水平因此，该项目是一个中心的一部分，其综合主题是影响分析， 团队的滥用责任专业知识，为FDA提供可用于指导法规制定的工具， 当法规生效时，已使用经过验证的方法对其进行测试、完善并生成 数据表明，其促进健康的效果最大化，意外后果最小化。