Studying the Impacts of Higher Taxes and Bans on Electronic Cigarettes to Improve Public Health
Design Tiered Tax Rates for Electronic Cigarettes (ECs) Based on Their Appeals to Youth and Young Adults
This clinical trial studies whether imposing higher taxes and bans on electronic cigarettes (EC) with appealing features impacts tobacco use among current and susceptible adolescents and young adults (AYA) EC users and adults who use EC or are open to EC use. ECs are currently the most popular form of nicotine or tobacco product in the United States. Compared to burned cigarette products, ECs generally pose fewer short-term harms, making them a promising tool for lowering users' exposure to toxins and cancer-causing chemicals from smoking, promoting better public health outcomes. However, evidence shows that EC marketing has increased overall initiation into nicotine use among AYAs, and that EC users are at a higher risk of becoming smokers, which could have negative public health outcomes. Therefore, understanding the public health impact of EC use and regulation remains a major goal in tobacco control research. This trial studies different scenarios which impose higher taxes or bans on ECs with appealing features. Researchers hope that by studying participant responses to the different scenarios they may be able to identify which ones best discourage EC use among AYAs while promoting adult EC users to quit smoking, which may improve public health.
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVES:
I. Provide empirical evidence on how tiered EC taxes - imposing higher taxes on ECs with AYA appealing features - impact EC use, combustible tobacco use, and the prevalence of cross-border or illegal purchases.
II. Examine how tiered taxes on AYA-appealing features (flavors, product type, nicotine concentration) impact EC use and combustible tobacco smoking among current and susceptible AYA EC users. (Aim 1) III. Assess how tiered taxes on AYA-appealing features impact EC and combustible tobacco smoking among adult smokers who either use or are open to using ECs. (Aim 2) IV. Compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on tobacco use, cross-border shopping, and illegal EC purchases. (Aim 3)
OUTLINE: Participants are assigned to 1 of 3 aims.
AIMS 1 & 2: Participants complete volumetric choice experiments (VCEs) over 20 minutes on study with random assignment to: 1) Nicotine levels (low versus [vs.] high); 2) Flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco); 3) EC tax bases (by product type vs. by flavor vs. by nicotine concentration), and 4) rate levels (status quo [equal rates] vs. 50% higher vs. 100% higher vs. 200% higher) among six different products (tanks, pods, disposables, cigarettes, cigars, and oral nicotine pouches [ONPs]) and opt-out options (none of the six products or quitting).
AIM 3: Participants are randomized to 1 of 2 groups.
GROUP 1: Participants complete VCEs over 20 minutes on study with random assignment to: 1) nicotine levels (low versus vs. high) and 2) flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco) with optimal tiered tax conditions among four different products (preferred EC type, cigarettes, cigars, ONPs) and opt-out options (none of the six products or quitting).
GROUP 2: Participants complete VCEs over 20 minutes on study with random assignment to: 1) nicotine levels (low versus vs. high), 2) flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco), and 3) purchasing sources (out-of-state legal vs. local/online illegal, vs. local legal) with banned conditions among four different products (preferred EC type, cigarettes, cigars, ONPs) and opt-out options (none of the six products or quitting).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：The Ohio State University Comprehensive Cancer Center
- 电话号码：800-293-5066
- 邮箱：OSUCCCClinicaltrials@osumc.edu
学习地点
-
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Ohio
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Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
-
接触：
- Ce Shang, PhD
- 电话号码：614-685-3741
- 邮箱：ce.shang@osumc.edu
-
首席研究员：
- Ce Shang, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- AYAs aged 15-24 who are daily or nondaily users of ECs and are not smoking in the past 30 days
- AYA tobacco nonusers aged 15-24 who are susceptible to EC or tobacco use (i.e., curiosity about the product, intention to try it in the near future, and likely response if a best friend were to offer them the product)
- Adults aged 18+ who are daily or nondaily users of ECs and combustible tobacco in the past 30 days
- Adults aged 18+ who are daily or nondaily users of combustible tobacco in the past 30 days, not currently using ECs but are open to trying ECs
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Aim 3 group 1 (tiered tax condition VCEs)
Participants complete VCEs over 20 minutes on study with random assignment to: 1) nicotine levels (low versus vs. high) and 2) flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco) with optimal tiered tax conditions among four different products (preferred EC type, cigarettes, cigars, ONPs) and opt-out options (none of the six products or quitting). |
Ancillary studies Complete EC tax base, rate, nicotine level, and flavor VCEs
其他名称：
Complete tiered tax condition VCEs
其他名称：
Complete banned condition VCEs
其他名称：
|
|
实验性的：Aim 3 group 2 (banned condition VCEs)
Participants complete VCEs over 20 minutes on study with random assignment to: 1) nicotine levels (low versus vs. high), 2) flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco), and 3) purchasing sources (out-of-state legal vs. local/online illegal, vs. local legal) with banned conditions among four different products (preferred EC type, cigarettes, cigars, ONPs) and opt-out options (none of the six products or quitting). |
Ancillary studies Complete EC tax base, rate, nicotine level, and flavor VCEs
其他名称：
Complete tiered tax condition VCEs
其他名称：
Complete banned condition VCEs
其他名称：
|
|
实验性的：Aims 1 & 2 (EC tax base and rate VCEs)
Participants complete VCEs over 20 minutes on study with random assignment to: 1) Nicotine levels (low vs. high); 2) Flavors (fruit/sweet vs. ice vs. menthol/mint vs. tobacco); 3) EC tax bases (by product type vs. by flavor vs. by nicotine concentration), and 4) rate levels (status quo [equal rates] vs. 50% higher vs. 100% higher vs. 200% higher) among six different products (tanks, pods, disposables, cigarettes, cigars, and oral nicotine pouches [ONPs]) and opt-out options (none of the six products or quitting). |
Ancillary studies Complete EC tax base, rate, nicotine level, and flavor VCEs
其他名称：
Complete tiered tax condition VCEs
其他名称：
Complete banned condition VCEs
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electronic cigarette (EC) use among adolescent and young adult (AYA) current/susceptible users (Aim 1)
大体时间：Up to 2 years
|
Will examine how tiered taxes on AYA-appealing features (flavors, product type, nicotine concentration) impact EC use among current and susceptible AYA EC users. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and Multiple Discrete-Continuous Extreme Value (MDCEV) Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Combustible tobacco smoking among AYA current/susceptible users (Aim 1)
大体时间：Up to 2 years
|
Will examine how tiered taxes on AYA-appealing features (flavors, product type, nicotine concentration) impact combustible tobacco smoking among current and susceptible AYA EC users. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
EC use among adult smokers who use or are open to ECs (Aim 2)
大体时间：Up to 2 years
|
Will assess how tiered taxes on AYA-appealing features (flavors, product type, nicotine concentration) impact EC smoking among adult smokers who either use or are open to using ECs. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Combustible tobacco smoking among adult smokers who use or are open to ECs (Aim 2)
大体时间：Up to 2 years
|
Will assess how tiered taxes on AYA-appealing features (flavors, product type, nicotine concentration) impact combustible tobacco smoking among adult smokers who either use or are open to using ECs. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Tobacco use among AYA EC current/susceptible users (Aim 3)
大体时间：Up to 2 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on tobacco use. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Cross-border shopping among AYA EC current/susceptible users (Aim 3)
大体时间：Up to 2 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on cross-border shopping. In order to assess differences in the proportion of cross-border EC purchases between the two randomization groups, the occurrence of a cross-border EC purchase will be modeled as a binary variable. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Illegal EC purchases among AYA EC current/susceptible users (Aim 3)
大体时间：Up to 2 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on illegal EC purchases. In order to assess differences in the proportion of illegal EC purchases between the two randomization groups, the occurrence of an illegal EC purchase will be modeled as a binary variable. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Tobacco use among adult smokers who use or are open to ECs (Aim 3)
大体时间：Up to 3 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on tobacco use. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 3 years
|
|
Cross-border shopping among adult smokers who use or are open to ECs (Aim 3)
大体时间：Up to 2 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on cross-border shopping. In order to assess differences in the proportion of cross-border EC purchases between the two randomization groups, the occurrence of a cross-border EC purchase will be modeled as a binary variable. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 2 years
|
|
Illegal EC purchases among adult smokers who use or are open to ECs (Aim 3)
大体时间：Up to 3 years
|
Will compare tiered EC taxes with sales bans on ECs with AYA-appealing features in terms of their impacts on illegal EC purchases. In order to assess differences in the proportion of illegal EC purchases between the two randomization groups, the occurrence of an illegal EC purchase will be modeled as a binary variable. All hypotheses will be tested using regression analyses. Will use count data models, such as the Negative Binomial model, the Poisson model, and MDCEV Model. Will use clustered sandwich estimators and consider mixed effects, random effects, and fixed effects in the modeling to account for the hierarchical structure (participant-choice set-purchase) and correlations among choices made by the same individual (repeated measures). Analyses will also control for sociodemographic characteristics such as age, sex, race/ethnicity, income, education, tobacco use histories/status, and purchase expenditures. |
Up to 3 years
|
合作者和调查者
调查人员
- 首席研究员：Ce Shang, PhD、Ohio State University Comprehensive Cancer Center
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- OSU-25157
- NCI-2026-02421 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- R01CA303567 (美国 NIH 拨款/合同)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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