Project 4

项目4

• 批准号: 10252834
• 负责人: Adam Matthew Leventhal
• 金额: $ 44.18万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252834
• 关键词: 3-Dimensional; Address; Adopted; Adult; Affect; Behavior; Cartoons; Characteristics; Cigarette; Data; Dimensions; Elderly; Electronic cigarette; Equilibrium; Face; Female; Flavoring; Health; Health Benefit; Human; Image; Label; Laboratories; Laboratory Research; Marketing; Masks; Measures; Menthol; Methods; Names; Nicotine; Nicotine Dependence; Outcome; Outcome Measure; Participant; Peach; Pharyngeal structure; Population; Population Heterogeneity; Propylene Glycols; Psychological reinforcement; Recording of previous events; Regulation; Research; Resources; Rewards; Risk; Sampling; Self Administration; Sensory; Sex Differences; Smoker; Smoking; Standardization; Study Subject; Taste Perception; Taste preferences; Testing; Thick; Tobacco; Tobacco use; Variant; Youth; addiction; age related; cigarette smoke; cohort; combustible tobacco; design; electronic cigarette use; electronic cigarette user; electronic liquid; experience; experimental study; interest; male; middle age; never smoker; never smoking; preference; sex; tobacco control; tobacco regulatory science; vaping; vapor; vegetable glycerin; young adult

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.

摘要：项目4(P4) 背景：电子烟对监管构成挑战，因为它们可能会对一些人的健康产生不利影响 减少人群(例如，从不吸烟的年轻人)，但降低其他人(例如，中年/老年吸烟者， 改用电子烟)。P4旨在向FDA提供证据，以告知监管机构对 电子烟产品多样性使从不吸烟的年轻人面临使用电子烟的风险，但并不能阻止 中老年吸烟者不会采用电子烟，并可能改用电子烟。P4将检验假设 关于产品多样性如何影响用户体验--接触的一个关键渠道：a)年轻人从不吸烟- 由于与年龄相关的口味偏好和掩盖薄荷醇的味道，消费者可能更喜欢带有甜味的电子液体 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品，b)E- 带有卡通形象和面向年轻人的产品名称的液体标签(如《Killer Kustard》)可能会更吸引人 年轻人(对中年/老年人)。C)电子液体中丙二醇(PG)/植物甘油(VG)的低比率 产生厚厚的蒸汽云和微弱的喉咙撞击，这可能对年轻人有吸引力，但对中老年人来说可能是有吸引力的 吸烟者可能更喜欢类似香烟烟雾的蒸汽。方法：从USC-TCORS队列和 人口核心资源，P4将比较从不吸烟的年轻成年电子烟使用者和中老年用户 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，受试者将 自行管理的电子烟产品根据口味(甜味、薄荷醇和烟草)而有系统地变化。 PG/VG比例(20：80 vs.40：60 vs.60：40 vs.80：20)×包装(e-Liquid表征风味标签[例如，“桃子”]) VS面向年轻人的非特色化味道[例如，《口香糖天堂》]VS非特色化味道+卡通)去- 签名。Aim 1研究将测试产品暴露对吸引力的主观评级(例如，喜欢、想使用)的影响 再一次)。Aim 2研究将测试产品暴露对选择使用(与赚钱)的影响：a)之前- 暴露的电子烟产品(滥用责任测试；仅限年轻人从不吸烟)，或b)自有品牌CIGA- RETES(抗烟能力测试；仅限中年/老年吸烟者)。目标1.确定哪些人是- 电子烟产品多样性对从不吸烟的年轻人电子烟的吸引力有不同影响 吸烟者(N=200)和中老年吸烟者(N=200)。目标2.确定电子烟产品的哪些维度- UCT多样性不同地影响从不吸烟的年轻成年电子烟使用者的滥用倾向(N=360)和能力 对中老年吸烟者(N=360)进行戒烟。与“产品交集”的整合 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的产品相同 USC-TCORS项目使用一种独特的受控实验范式来揭示因果机制。P4有一个 次要目标(目标3)，将确定人口性别多样性如何改变 电子烟产品。FDA涉及的科学领域：成瘾、行为和营销。