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，据估计占全球所有死亡人数的9%。使用烟草产品对人口造成的伤害程度(即死亡率和疾病率)取决于使用数量(产品使用的流行率和强度)和所使用产品的毒性。为了确定新烟草产品的推出将如何影响人口危害，我们需要更敏感和更全面的程序来评估滥用责任，包括使用新烟草产品取代或与香烟等传统烟草产品一起使用的可能性。经过几十年的发展，目前的药物滥用责任评估方法已被证明具有良好的外部和预测性有效性。然而，准确评估烟草产品的滥用责任将需要更高的敏感性，以(1)发现类似产品数量不断增加之间的差异，(2)承认并纳入可能影响使用可能性或程度的环境和情景因素，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，我们的目标是将行为经济学方法应用于开发更敏感和更全面的烟草产品滥用责任评估方法。具体地说，我们将在三个不同成本和努力的平台或方法上使用这些滥用责任评估的行为经济学方法(例如，人类实验室、生态评估和问卷调查)。修改后的滥用责任方法纳入了行为经济学分析，预计将导致对可能推出新产品和避免过去错误所造成的潜在人口伤害进行更准确的评估。 具体地说，在具体目标1中，我们将在实验室环境下，以门诊为基础，使用基于问卷的方法，将潜在的改良风险烟草产品骆驼鼻(口服、无唾液烟草袋)的需求函数与传统香烟(对滥用物质进行积极控制)和医用尼古丁(对较低滥用风险更安全的产品进行消极控制)的需求函数进行比较。在目标2中，我们将调查不同价格范围内的产品选择 这些平台中。在目标3中，我们将研究改变卷烟价格可能如何影响在每一种相同设置下的替代产品的消费。在目标4中，我们将在以下方面对三个评估程序和三个平台进行比较：(1)对项目4中提议的临床试验进行相同的评估、评估成本和预测。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迫切需要的信息，用于评估启动和继续使用这些产品的可能性，这可能会影响公众健康。此外，更多的发展 本申请中提议的敏感的滥用责任方法有可能确定对改性风险烟草产品进行滥用责任评估所依据的标准。

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.