Project 4

摘要：项目4（P4） 背景：电子烟构成了监管挑战，因为它们可能会对一些人的健康产生不利影响。 群体（例如，年轻的不吸烟者），但减少其他人的健康风险（例如，中年/老年吸烟者， 转向电子烟）。P4旨在为FDA提供证据，以告知 电子烟产品的多样性使年轻的成年人不吸烟者面临使用电子烟的风险，但并没有阻止 中/老年人吸烟者采用并可能转向电子烟。P4将检验假设 关于产品多样性如何影响用户体验-一个关键的曝光渠道：a）年轻的从不吸烟- 由于年龄相关的口味偏好和掩盖了的薄荷醇口味， 尼古丁的苦味;然而，中年/成年吸烟者可能更习惯于烟草调味剂，B）E- 具有卡通图像和面向青年的产品名称的液体标签（例如，“杀手Kustard”）可能更吸引 年轻人（相对于中年/老年人）。c）电子液体产品中的低丙二醇（PG）/植物甘油（VG）比率 吸入厚厚的“蒸汽云”和微弱的喉咙冲击，这可能会吸引年轻人，但中年/老年人 吸烟者可能更喜欢类似香烟烟雾的蒸汽。方法：从USC-TCORS队列中抽取数据， 人口核心资源，P4将比较从不吸烟的年轻成人电子烟使用者与中年/老年人 对电子烟感兴趣但没有显著经验的成年吸烟者。在两项研究中，受试者 根据口味（甜味vs.薄荷醇vs.烟草）系统性变化的自我管理电子烟产品 PG/VG比率（20：80对比40：60对比60：40对比80：20）×包装（电子液体表征风味标签[例如，“peach”] vs.面向年轻人的非特征性风味[例如，“橡皮糖天堂”] vs.非特征化风味+卡通）de- 标志.目标1研究将测试产品接触对主观上诉评级的影响（例如，喜欢，渴望使用 再次）。目标2研究将测试产品暴露对选择使用（与赚钱）的影响：a）以前的- 暴露的电子烟产品（滥用责任测试;仅限从不吸烟的年轻人），或B）自有品牌雪茄- Rettes（抵抗吸烟能力测试;仅限中年/老年吸烟者）。目标1.确定哪些尺寸- 电子烟产品多样性对从不吸烟的年轻成人电子烟的吸引力有不同的影响 吸烟者（N=200）和中年/老年吸烟者（N=200）。目标2.确定电子烟产品的哪些尺寸- 电子烟多样性对从不吸烟的年轻成年电子烟使用者（N=360）的滥用倾向和能力产生不同影响 在中年/老年吸烟者中戒烟（N=360）。与“产品与 人口”主题：P4将研究电子烟产品多样性的维度，这些维度与其他研究中的维度相同。 USC-TCORS项目使用独特的受控实验范式来告知因果机制。P4有一个 第二个目标（目标3），将确定人口性别多样性如何改变的吸引力和滥用的可能性， 电子烟产品。FDA科学领域：成瘾、行为和营销。

ABSTRACT: PROJECT 4 (P4) Background: E-cigarettes pose a regulatory challenge because they may adversely impact the health of some populations (e.g., young never-smokers), but reduce health risk in others (e.g., middle-aged/older smokers who switch to e-cigarettes). P4 aims to provide FDA with evidence to inform regulatory restrictions of dimensions of e-cigarette product diversity that put young adult never-smokers at risk of using e-cigarettes, yet does not deter middle/older adult smokers from adopting and potentially switching to e-cigarettes. P4 will test the hypotheses regarding how product diversity impacts the user experience—a key channel of exposure: a) Young never-smok- ers may prefer e-liquids with sweet flavorings due to age-related taste preferences and menthol flavors that mask the bitterness of nicotine; yet, middle-age/adult smokers may be more accustomed to tobacco flavorings, b) E- liquid labels with cartoon images and youth-oriented product names (e.g., ‘Killer Kustard’) may appeal more to young (vs. middle-age/older) adults. c) Low propylene glycol (PG)/vegetable glycerin (VG) ratio in e-liquids pro- duces thick ‘vapor clouds’ and a weak throat hit, which may appeal to young adults, but middle-age/older adult smokers may prefer vapor that resembles cigarette smoke. Method: Drawing from the USC-TCORS cohort and Population Core resources, P4 will compare never-smoking young adult e-cigarette users to middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes. In two studies, subjects will self-administer e-cigarette products systematically varied according to Flavor (sweet vs. menthol vs. tobacco) × PG/VG ratio (20:80 vs. 40:60 vs. 60:40 vs. 80:20) × Packaging (e-liquid characterizing flavor label [e.g., “peach”] vs. youth-oriented non-characterizing flavor [e.g., “gummy heaven”] vs. non-characterizing flavor + cartoon) de- sign. The Aim 1 study will test product exposure effects on subjective ratings of appeal (e.g., liking, desire to use again). The Aim 2 study will test product exposure effects on choice to use (vs. earn money): a) The previously- exposed e-cigarette product (an abuse liability test; never-smoking young adults only), or b) Own brand ciga- rettes (test of ability to resist smoking; middle-age/older adult smokers only). Aim 1. Determine which dimen- sions of e-cigarette product diversity differentially affect appeal across never-smoking young adult e-cigarette users (N=200) and middle-age/older smokers (N=200). Aim 2. Determine which dimensions of e-cigarette prod- uct diversity differentially affect abuse liability in never-smoking young adult e-cigarette users (N=360) and ability to resist smoking in middle-age/older adult smokers (N=360). Integration with “Intersections of Products with Populations” theme: P4 will study dimensions of e-cigarette product diversity common to those studied in other USC-TCORS projects using a unique controlled experimental paradigm to inform causal mechanisms. P4 has a secondary aim (Aim 3) that will determine how population diversity in sex alters the appeal and abuse liability of e-cigarette products. FDA Scientific domains addressed: Addiction, Behavior, and Marketing.