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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-02421 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 3 group 1 (tiered tax condition VCEs) | Experimental | 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). |
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| Aim 3 group 2 (banned condition VCEs) | Experimental | 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). |
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| Aims 1 & 2 (EC tax base and rate VCEs) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discrete Choice Study | Other | Complete EC tax base, rate, nicotine level, and flavor VCEs |
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| Measure | Description | Time Frame |
|---|---|---|
| Electronic cigarette (EC) use among adolescent and young adult (AYA) current/susceptible users (Aim 1) | 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) | 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) | 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. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ce Shang, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
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| The Jamesline | View source |
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To address aims 1-2 (how tiered EC taxes impact tobacco use), will conduct two VCEs with manipulations of flavors, nicotine concentration, EC tiered tax bases, and EC tiered rates to determine the combination of EC tiered tax bases and rates that result in the greatest net public health impacts in years 1-2. Next, the optimal combination or EC tiered tax design will be compared to EC bans in aim 3, which will be examined in years 3-4 using split-sample VCEs with randomization.
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| Discrete Choice Study | Other | Complete tiered tax condition VCEs |
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| Discrete Choice Study | Other | Complete banned condition VCEs |
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| Survey Administration | Other | Ancillary studies |
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| Up to 2 years |
| Combustible tobacco smoking among adult smokers who use or are open to ECs (Aim 2) | 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) | 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) | 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) | 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) | 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) | 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) | 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 |