Research Project 2 : Sweet and Cooling Flavors and Nicotine: Examinations in New and Established Tobacco Product Users

摘要：项目#2 大多数烟草产品含有各种各样的香料。流行病学证据表明，虽然 调味烟草产品被所有年龄段的烟草使用者使用，年轻的烟草使用者似乎 与年长的烟草使用者相比，他们更喜欢口味。此外，青年人 开始使用烟草的人经常报告说，吸引人的口味的可用性是他们吸烟的主要原因之一。 尝试和使用某些烟草/尼古丁产品，如电子烟（e-cigs），雪茄和水烟。尽管 根据这一证据，FDA-CTP除了禁止所有口味外，没有提出关于口味的新规定 除了2009年香烟中的薄荷醇。缺乏行动可能与缺乏适当的 关于香料是否会改变烟草/尼古丁产品的吸引力和滥用潜力的科学证据。 香料可以改变尼古丁/烟草的吸引力和滥用潜力，无论是通过初级强化， 风味特征（例如诱人的香气或味道）直接增加产品的吸引力和滥用 潜在的，或通过改善烟草/尼古丁的厌恶特性（此后称为“改善”）， 属性/效果）。这个项目的目标是产生关键的证据的作用，风味，以告知 并支持FDA对调味烟草/尼古丁产品的规定。我们将确定的影响， “香气和味道”和“改善”属性的流行甜和薄荷口味的吸引力和使用 电子烟这个项目将使用电子烟，因为它们提供了一个理想的系统，检查吸入 有多种不同的口味（7000多种）可供选择。研究1将使用已建立的 方法学和感官实验，以检查甜，凉和烟草风味的影响， 其组合，对含有尼古丁浓度的电子烟的吸引力和滥用潜力的影响 不同的苛刻（3毫克/毫升，12毫克/毫升），在易受影响的青年谁可能开始使用电子烟。 这项研究还将探讨对味道的感官反应是否能预测电子烟和其他产品中的出现。 在6个月和1年的随访中，研究2将使用已建立的实验 检查不同种类的风味剂（即，甜、凉、烟草），当与尼古丁结合时 浓度不同的苛刻（6和18毫克/毫升）改变吸引力和尼古丁奖励之间的年轻人 和年长的可燃烟草使用者。重要的是，这项研究还将探讨不同的影响， 甜味剂、清凉剂和烟草香料对从使用可燃烟草产品转向使用电子烟影响， 年轻人和老年人使用可燃烟草。从这一新颖的提议中产生的证据是 关键是支持针对烟草/尼古丁产品（如电子烟）口味的法规， 我们需要在减少这些产品对青少年的吸引力和提高他们的 呼吁希望改用电子烟以减少危害的可燃烟草使用者。

Abstract: Project #2 Most tobacco products contain a wide variety of flavors. Epidemiological evidence suggests that while flavored tobacco products are used by tobacco users of all ages, younger tobacco users seem to have greater preference for flavors, when compared with older tobacco users. Furthermore, youth who are initiating tobacco use often report the availability of appealing flavors as one of the primary reasons for trying and using certain tobacco/nicotine products, like e-cigarettes (e-cigs), cigars and hookahs. Despite this evidence, the FDA-CTP has not proposed new regulations on flavors, other than the ban on all flavors except menthol in cigarettes in 2009. This lack of action could be related to the dearth of adequate scientific evidence on whether flavors alter appeal and abuse potential of tobacco/nicotine products. Flavors could alter appeal and abuse potential of nicotine/tobacco, either through the primary reinforcing characteristics of flavor (e.g. appealing aroma or taste) directly increasing product appeal and abuse potential, or by ameliorating aversive characteristics of tobacco/nicotine (henceforth “ameliorating” attributes/effects). The goal of this project is to generate critical evidence on the role of flavors to inform and support FDA regulations on flavored tobacco/nicotine products. We will determine the influence of the “aroma and taste” and “ameliorating” attributes of popular sweet and menthol flavors on the appeal and use of e-cigs. This project will use e-cigs because they provide an ideal system for examining the inhaled effects of flavors and nicotine, and are available in different (7000+) flavors. Study 1 will use established methodology and sensory experiments to examine the influence of sweet, cool and tobacco flavors, and combinations thereof, on the appeal and abuse potential of e-cigs containing nicotine concentrations varying in harshness (3 mg/ml, 12 mg/ml), among susceptible youth who are likely to initiate e-cig use. This study will also explore if sensory responses to flavors predict emergence in e-cigarette and other tobacco use behaviors at six-month and one-year follow ups. Study 2 will use established experimental methods to examine if different classes of flavors (i.e., sweet, cool, tobacco), when combined with nicotine concentrations differing in harshness (6 and 18 mg/ml) alter appeal and nicotine reward among younger and older combustible tobacco users. Importantly, this study will also explore the differential influence of sweet, cool, and tobacco flavors on switching from combustible tobacco product use to e-cigarettes, among younger and older adult combustible tobacco users. The evidence generated from this novel proposal is crucial to support regulations directed at flavors in tobacco/nicotine products like e-cigs, which will likely need to strike a balance between reducing the appeal of these products for youth and enhancing their appeal for combustible tobacco users looking to switch to use of e-cigs for harm-reduction.