Smoking BehaviorsAIM2NCT06795997
Tobacco/Nicotine Purchase Patterns Across SES
A study testing Tax Conditions in people with Smoking Behaviors and Smoking, Non-Tobacco Products, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
In a within-subject design, investigators will use the Experimental Tobacco Marketplace (ETM) to systematically impose 4 novel tobacco/nicotine tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) covering a broad range of tax magnitudes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors, Smoking, Non-Tobacco Products, Smoking, Cigarette
- What is being tested?
- Tax Conditions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- provide informed consent
- be at least 21 years of age
- smoke at least 10 cigarettes daily and use other tobacco products less than weekly
Who cannot join
- pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: ETM Taxes: The Impact of Innovative Tax Proposals on Purchase Patterns Across SES
In a within-subject design, investigators will use the Experimental Tobacco Marketplace (ETM) to systematically impose 4 novel tobacco/nicotine tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) covering a broad range of tax magnitudes. Participants will complete one control trial and all conditions (tax proposals) in the ETM with 5 trials each. Analyses will model the quantity of the product purchased as a function of tax tier (i.e., high, medium, no tax) and examine poly-tobacco purchasing.
Read the detailed description
Although taxes have been studied in econometric and quasi-experimental studies, the ETM is the only experimental laboratory model that has examined the impact of taxes on purchasing behavior. In pilot data collected originally for the prior version of this grant's application, investigators examined the Tobacco Parity Tax and Harm-Reduction Tax among exclusive cigarette smokers (n=35) in an online hypothetical ETM. Briefly, each tax proposal had 3 tax tiers (see C.1 Implementation of Tax Proposals, for the rationale) in the ETM with a subset of products. Therein, the Tobacco Parity Tax decreased purchases from the highest tax tier (p<0.001; f=0.49) and increased purchases of the no-tax tier (nicotine gum/lozenges were the most purchased; p<0.001; f=0.36) as taxes increased.
Conversely, the Harm-Reduction Tax resulted in greater purchases from the middle tier as tax constraints increased (ENDS were the most purchased; p<0.001; f=0.29). Moreover, the Harm-Reduction Tax elicited a greater substitution of medium-tiered products compared to the Tobacco Parity Tax (p<0.001; f=0.15). In follow-up secondary analyses of this preliminary data, investigators stratified these tax proposal by SES and found the largest effect in the Harm-Reduction Tax with the low SES group exhibiting the highest substitution of medium-tax tier products compared to more affluent groups (ps<0.001; f=0.16; Fig. 3). These results must be replicated with larger samples. In this study, investigators will ensure socioeconomic representation reflective of the US population. Given the robust effect of tax magnitude, investigators will also examine purchasing across a broad range of magnitudes to fully characterize each novel tax proposal-thereby discerning how smokers will defend their consumption or substitute with other products.
Participants will complete a one session study including consent and behavioral tasks (ETM and smoking-related assessments). A Qualtrics survey will administer:
- the electronic informed consent; Participants will read through the informed consent and consent will be implied with submission of the assessment at the end of the survey.
- smoking-related assessments
- timeline follow back, to assess previous month recent smoking, e-cigarette use and consumption of nicotine products, and to determine ETM budget
- tobacco use history, exposure and preferences questions;
- the Fagerstrom Test of Nicotine Dependence for cigarettes and the Heaviness of Smoking Index for e-cigarettes to assess dependence.
- the ETM; Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price: Tobacco Parity, Nicotine-Content, Harm- Reduction, and Modified Risk Tobacco Product-related taxes.
- Being tested
- Tax Conditions, Control Condition
- Keywords
- Experimental Tobacco Marketplace, Tobacco Regulatory Policy
- Medical subject headings
- Smoking, Smoking, Non-Tobacco Products, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tax ConditionsBehavioural
Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to 4 conditions with 5 trials each, where products will increase in price: Tobacco Parity, Nicotine-Content, Harm- Reduction, and Modified Risk Tobacco Product-related taxes.
Control ConditionBehavioural
Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Cigarette Smokers | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to all of the tax conditions described in the intervention section. Receives: Behavioral: Tax Conditions |
| Exclusive Cigarette Smokers-Control Condition | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to the control condition described in the intervention section. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Product Purchasing
Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days
Measured: During a one-session study, participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start16 Dec 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-subject design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Jeff Stein, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795997
- Sponsor's protocol ID
- VT IRB 24-1228
- Other IDs
- 5R01CA266966
- Acronym
- AIM2
- Status last verified
- May 2025
- First submitted
- 25 Nov 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freitas-Lemos R, Bruckner LE, Xu S, Mason MG, Tegge AN, Stein JS, Sheffer CE, Bickel WK. Impact of four tobacco tax policies on tobacco product purchasing patterns across socioeconomic groups. Tob Control. 2026 Apr 1:tc-2025-059541. doi: 10.1136/tc-2025-059541. Online ahead of print.
PubMed 41922170
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETM Taxes: The Impact of Innovative Tax Proposals on Purchase Patterns Across SES
- ClinicalTrials.gov ID
- NCT06795997
- Acronym / sponsor ID
- AIM2 / VT IRB 24-1228
- Keywords
- Experimental Tobacco Marketplace, Tobacco Regulatory Policy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a within-subject design, investigators will use the Experimental Tobacco Marketplace (ETM) to systematically impose 4 novel tobacco/nicotine tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) covering a broad range of tax magnitudes. Participants will complete one control trial and all conditions (tax proposals) in the ETM with 5 trials each. Analyses will model the quantity of the product purchased as a function of tax tier (i.e., high, medium, no tax) and examine poly-tobacco purchasing.
Detailed description
Although taxes have been studied in econometric and quasi-experimental studies, the ETM is the only experimental laboratory model that has examined the impact of taxes on purchasing behavior. In pilot data collected originally for the prior version of this grant's application, investigators examined the Tobacco Parity Tax and Harm-Reduction Tax among exclusive cigarette smokers (n=35) in an online hypothetical ETM. Briefly, each tax proposal had 3 tax tiers (see C.1 Implementation of Tax Proposals, for the rationale) in the ETM with a subset of products. Therein, the Tobacco Parity Tax decreased purchases from the highest tax tier (p<0.001; f=0.49) and increased purchases of the no-tax tier (nicotine gum/lozenges were the most purchased; p<0.001; f=0.36) as taxes increased.
Conversely, the Harm-Reduction Tax resulted in greater purchases from the middle tier as tax constraints increased (ENDS were the most purchased; p<0.001; f=0.29). Moreover, the Harm-Reduction Tax elicited a greater substitution of medium-tiered products compared to the Tobacco Parity Tax (p<0.001; f=0.15). In follow-up secondary analyses of this preliminary data, investigators stratified these tax proposal by SES and found the largest effect in the Harm-Reduction Tax with the low SES group exhibiting the highest substitution of medium-tax tier products compared to more affluent groups (ps<0.001; f=0.16; Fig. 3). These results must be replicated with larger samples. In this study, investigators will ensure socioeconomic representation reflective of the US population. Given the robust effect of tax magnitude, investigators will also examine purchasing across a broad range of magnitudes to fully characterize each novel tax proposal-thereby discerning how smokers will defend their consumption or substitute with other products.
Participants will complete a one session study including consent and behavioral tasks (ETM and smoking-related assessments). A Qualtrics survey will administer:
- the electronic informed consent; Participants will read through the informed consent and consent will be implied with submission of the assessment at the end of the survey.
- smoking-related assessments
- timeline follow back, to assess previous month recent smoking, e-cigarette use and consumption of nicotine products, and to determine ETM budget
- tobacco use history, exposure and preferences questions;
- the Fagerstrom Test of Nicotine Dependence for cigarettes and the Heaviness of Smoking Index for e-cigarettes to assess dependence.
- the ETM; Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price: Tobacco Parity, Nicotine-Content, Harm- Reduction, and Modified Risk Tobacco Product-related taxes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Within-subject design
| Arm | Type | Receives |
|---|---|---|
| Exclusive Cigarette Smokers | Experimental | Behavioral: Tax ConditionsExclusive cigarette smokers will be recruited and will be exposed to all of the tax conditions described in the intervention section. |
| Exclusive Cigarette Smokers-Control Condition | Experimental | Behavioral: Control ConditionExclusive cigarette smokers will be recruited and will be exposed to the control condition described in the intervention section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provide informed consent
- be at least 21 years of age
- smoke at least 10 cigarettes daily and use other tobacco products less than weekly
Key exclusion criteria (1 listed)
- pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tax ConditionsParticipants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to 4 conditions with 5 trials each, where products will increase in price: Tobacco Parity, Nicotine-Content, Harm- Reduction, and Modified Risk Tobacco Product-related taxes. | Behavioural | Exclusive Cigarette Smokers |
| Control ConditionParticipants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial. | Behavioural | Exclusive Cigarette Smokers-Control Condition |
Primary outcome
Tobacco Product Purchasing
Time frame: During a one-session study, participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price
Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41922170Freitas-Lemos R, Bruckner LE, Xu S, Mason MG, Tegge AN, Stein JS, Sheffer CE, Bickel WK. Impact of four tobacco tax policies on tobacco product purchasing patterns across socioeconomic groups. Tob Control. 2026 Apr 1:tc-2025-059541. doi: 10.1136/tc-2025-059541. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Stein, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tax Conditions in people with Smoking Behaviors and Smoking, Non-Tobacco Products, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Product Purchasing (time frame: During a one-session study, participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.