The Pilot Projects Program of the USC TCORS aims to support new and innovative research relevant to the regulation of tobacco products by the Food and Drug Administration (FDA). We are seeking to prioritize funding support for newer/junior researchers who can use the pilot project process as a capacity building and career enhancing opportunity in tobacco regulatory science (TRS).
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The current laboratory study will evaluate differences in appeal ratings, tobacco withdrawal, and smoking motivation across three e-cigarette solutions (i.e., menthol, mint, or tobacco flavor) in 30 adult menthol cigarette smokers. Findings will inform future regulatory decisions on whether menthol and mint flavors: 1) promote initiation and transitions to use of e-cigarettes in menthol cigarette smokers; and 2) alter patterns of menthol smoking by suppressing tobacco withdrawal and smoking motivation when e-cigarette flavors are accessible.
The specific aims of this laboratory study are:
Aim 1. To evaluate differences in subjective ratings of appeal after administration of menthol, mint, and tobacco-flavored e-cigarettes in e-cigarette naïve, adult menthol cigarette smokers.
Aim 2. To examine effects of menthol, mint, and tobacco-flavored e-cigarettes on tobacco withdrawal in e-cigarette naïve, adult menthol cigarette smokers.
Aim 3. To examine effects of menthol, mint, and tobacco-flavored e-cigarettes on motivation to smoke menthol combustible cigarettes when a flavored e-cigarette option is available.
The overall goal of this project is to examine how different methods of poly-tobacco use measurement contribute to overall poly-tobacco use prevalence estimates and to adverse mental health outcomes. A sample of 2,000 young adult (aged 18-25 years) e-cigarette users will complete an online questionnaire assessing use of other tobacco products, reasons for engaging in poly-tobacco use, patterns of poly-tobacco use relative to e-cigarette use, and depression and anxiety screenings. Individuals with depression and/or anxiety engage in poly-tobacco use at higher rates than the general population and understanding the impact of various poly-tobacco use patterns on adverse mental health outcomes will be a practical way to ensure cohesive conclusions are drawn across studies.
Aim 1: Estimate the prevalence of poly-tobacco use among current e-cigarette users across three different methods of measuring poly-tobacco use. The three measurement methods to be compared are: select all tobacco products used in past thirty days, frequency of other tobacco product use relative to e-cigarette use, and number of days used multiple tobacco products on the same day in the past thirty days.
Aim 2: Evaluate the association of each of the three methods of poly-tobacco use measurement, referenced above in Aim 1, with common outcome measures, depression or anxiety, and compare adjusted ORs generated from multivariate logistic regression models.
Aim 3: Generate several succinct constructs of reasons for poly-tobacco use in a post-hoc factor analysis to be used as predictors in multivariate logistic regression models, with dichotomous depression or anxiety variables as the outcomes.
E-liquid nicotine concentrations are labeled as mg/ml or % nicotine. However, these metrics may be confusing, especially for youth, and could result in inadvertent exposure to high nicotine levels. The current project is designed to evaluate whether using novel text-based labels (e.g., “high nicotine level”) or graphic-based labels (e.g., a nicotine thermometer) improves young e-cigarette users’ understanding of nicotine strength and addiction potential. First, subject matter experts will develop the new labels. Second, adolescents and young adults’ ability to understand current labeling metrics (mg/ml; %) will be assessed. Third, the new labels will be tested against current labels to determine if using lay labels (text or graphic) improves young users’ understanding of nicotine strength and related harm. If supported, the new label(s) could be used in future research on the development and correlates of vaping behavior and could inform FDA’s regulatory efforts.
Aim 1: Developing novel text and graphic nicotine concentration labels.
Aim 2: Examining the extent to which youth misunderstand current nicotine concentration labels
Aim 3: Evaluating whether using text- or graphic-based nicotine concentration labelsimproves understanding of nicotine content and addictive potentia