- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581041
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: The Ohio State University Comprehensive Cancer Center
- Phone Number: 800-293-5066
- Email: OSUCCCClinicaltrials@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Ce Shang, PhD
- Phone Number: 614-685-3741
- Email: ce.shang@osumc.edu
-
Principal Investigator:
- Ce Shang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
Other Names:
Complete tiered tax condition VCEs
Other Names:
Complete banned condition VCEs
Other Names:
|
|
Experimental: 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
Other Names:
Complete tiered tax condition VCEs
Other Names:
Complete banned condition VCEs
Other Names:
|
|
Experimental: 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
Other Names:
Complete tiered tax condition VCEs
Other Names:
Complete banned condition VCEs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electronic cigarette (EC) use among adolescent and young adult (AYA) current/susceptible users (Aim 1)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ce Shang, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OSU-25157
- NCI-2026-02421 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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