Behavioral Economic Methods for Assessing Tobacco Product Abuse Liability

项目总结（见说明）： 烟草使用是导致死亡的第二大风险因素，估计占全球所有死亡人数的9%。危害程度（即，由于使用烟草制品而对人口造成的死亡率和疾病率（包括死亡率和疾病率）取决于使用的规模（产品使用的流行率和强度）和所用产品的毒性。为了确定新烟草产品的引入将如何影响人口危害，我们需要更敏感和全面的滥用责任评估程序，包括新烟草产品将取代传统烟草产品（如香烟）或与传统烟草产品一起使用的可能性。几十年来发展起来的药物滥用倾向评估方法已被证明具有良好的外部和预测有效性。然而，准确评估烟草制品的滥用倾向将需要更高的敏感性，以（1）检测越来越多的类似产品之间的差异，（2）承认并纳入可能影响使用可能性或程度的环境和情境因素，以及（3）提供区分可能一起使用的产品与可能相互替代的产品的能力。在项目2中，我们的目标是应用行为经济学方法来开发更敏感和更全面的烟草制品滥用责任评估方法。具体来说，我们将在三个平台或方法上使用这些行为经济学方法进行滥用责任评估，这些平台或方法的成本和努力各不相同（例如，人类实验室、生态评估和问卷调查）。采用行为经济学分析的经修改的滥用责任方法，预计将导致对可能推出的新产品和避免过去的错误所造成的潜在人口伤害进行更准确的评估。 具体来说，在具体目标1中，我们将比较潜在风险改变烟草产品骆驼鼻烟的需求函数（口腔，少吐烟草袋），以要求传统香烟的功能（滥用物质的阳性对照）和药用尼古丁（低滥用风险更安全产品的阴性对照）在实验室环境中，在门诊基础上，并使用基于虹膜的方法。在目标2中，我们将调查每个国家不同价格范围内的产品选择。 这些平台。在目标3中，我们将研究卷烟价格的变化如何影响在每一个相同的环境中替代产品的消费。在目标4中，在所有研究中，我们将比较三种评估程序和三种平台（1）提供相同的评估，评估成本和项目4中提出的临床试验预测。鉴于最近的立法赋予FDA对烟草产品的广泛监管权力，这些研究将提供及时和急需的信息，以评估开始和继续使用这些产品的可能性，这些产品有可能影响公共健康。此外，发展更多 本申请中提出的敏感的滥用责任方法有可能确定对风险改变的烟草产品进行滥用责任评估的标准。

PROJECT SUMMARY (See instructions): Tobacco use is the second leading risk factor for death, estimated to be responsible for 9% of all deaths worldwide. The degree of harm (i.e., rates of death and disease) to the population due to use of tobacco products is dependent on both magnitude of use (prevalence and intensity of product use) and toxicity of the products used. To determine how the introduction of new tobacco products would affect population harm, we need more sensitive and comprehensive procedures for abuse liability assessment, including the likelihood that a new tobacco product will be used in place of, or together with, conventional tobacco products such as cigarettes. Current methods of abuse liability assessment of drugs developed over several decades have been shown to have excellent external and predictive validity. However, accurate assessment of the abuse liability of tobacco products will require greater sensitivity to (1) detect differences between the increasing number of similar products, (2) acknowledge and incorporate environmental and situational factors that can affect the likelihood or magnitude of use, and (3) provide the ability to distinguish between products that might be used together compared to those that might substitute for each other. In Project 2, we aim to apply a behavioral economic approach to the development of more sensitive and comprehensive abuse liability assessment methods for tobacco products. Specifically, we will use these behavioral economic methods of abuse liability assessment across three platforms or approaches that vary in cost, and effort (e.g., human laboratory, ecological assessment, and questionnaire). Modified abuse liability methodology that incorporates behavioral economic analyses is expected to lead to more accurate assessments of potential population harm from the possible introduction of new products and the avoidance of past mistakes. Specifically, in Specific Aim 1, we will compare the demand function for a potential modified-risk tobacco product, Camel snus (oral, spit-less tobacco pouches), to demand functions for conventional cigarettes (positive control for an abused substance) and for medicinal nicotine (negative control for a low abuse liability safer product) across a range of prices in the laboratory setting, on an outpatient basis, and using questionnaire-based methods. In Aim 2, we will investigate product choice across a range of prices in each of these platforms. In Aim 3, we will examine how changing the price of cigarettes might affect the consumption of alternative products in each of the same settings. In Aim 4, across all the studies we will compare the three assessment procedures and three platforms in terms of (1) rendering the same assessment, cost of assessment and prediction of the clinical trial proposed in Project 4. In light of recent legislation giving FDA broad regulatory authority over tobacco products, these studies will provide timely and much needed information regarding the methods to use to assess the likelihood of initiation and continued use of these products, which have the potential to impact public health. Moreover, the development of more sensitive abuse liability methodology as proposed in this application has the potential to define the standards by which abuse liability assessment of modified-risk tobacco products is conducted.