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Project 4

项目4

基本信息

批准号：
10005308
负责人：
Adam Matthew Leventhal
金额：
$ 68.12万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
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/10005308
关键词：
3-Dimensional Address Adopted Adult Affect Behavior Cartoons Characteristics Cigarette Data Dimensions Elderly Electronic cigarette Equilibrium Face Female Flavoring Glycerol 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 Vegetables Youth addiction age related cigarette smoke cohort 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 young adult

项目摘要

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）