Cigarette SmokingNCT05370313
The Impact of Innovative Tax Proposals on Purchase Patterns
A study testing Tobacco Parity Tax Condition, Nicotine-Content Tax Condition and Harm-Reduction Tax Condition in people with Cigarette Smoking, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
Trial summary
This study will investigate the effect of four tax proposals (i.e. Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) on tobacco product purchasing patterns. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Tobacco Parity Tax Condition, Nicotine-Content Tax Condition and Harm-Reduction Tax Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Apr 2023to 10 Jun 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provide informed consent
- provide a breath carbon monoxide sample ≥ 8 ppm,
- be at least 21 years of age (the legal age to purchase tobacco),
- smoke at least 10 cigarettes daily, and
- use other tobacco products less than weekly.
Who cannot join
- report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
- use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
- report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
- be pregnant or lactating, or
- have plans to move out of the area during the experiment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: ETM Taxes Study 1: The Impact of Innovative Tax Proposals on Purchase Patterns
This study will investigate the effect of four tax proposals (i.e. Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) on tobacco product purchasing patterns.
Read the detailed description
This study experimentally examines the effects of largely untried integrated tax proposals. Four tax proposals will be modeled: Tobacco Parity, Nicotine-Content, Harm-Reduction, and MRTP. Tobacco products are placed into three tax tiers: high-, medium-, and no-tax, according to the goals of each proposal. In a within-subjects design, cigarette smokers will complete two control (market price) trials and four conditions in the Experimental Tobacco Marketplace, representing each of the four tax proposals. Within each condition, taxes will be increased proportionally across 5 trials (relative to tax tier) to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
- Conditions
- Cigarette Smoking
- Being tested
- Market Price Condition (control), Tobacco Parity Tax Condition, Nicotine-Content Tax Condition, Harm-Reduction Tax Condition, Modified Risk Tobacco Product (MRTP) Tax Condition
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Market Price Condition (control)Behavioural
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Cigarette taxes increased across trials at the same magnitudes used in the tax conditions.
Tobacco Parity Tax ConditionBehavioural
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all tobacco products are placed in the high-tax tier while products that do not contain tobacco (e.g., herbal cigarettes and nicotine-free ENDS) are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier.
Nicotine-Content Tax ConditionBehavioural
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, products with greater than 3 mg nicotine per single unit are placed in the high-tax tier, products with 0.6-3.0 mg/unit in the medium-tax tier, and those with 0.5 mg/unit or less in the no-tax tier.
Harm-Reduction Tax ConditionBehavioural
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all combustible products with high abuse liability are placed in the high-tax tier. All non-combustible products or combustible products with low abuse liability are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier.
Modified Risk Tobacco Product (MRTP) Tax ConditionBehavioural
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all non-MRTP tobacco products are placed in the high-tax tier, MRTPs are placed in the medium-tax tier, and Nicotine Replacement Therapy products are placed in the no-tax tier.
| Study group | Role | What they receive |
|---|---|---|
| Cigarette smokers - Sequence 1 | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the four tax policy conditions in this sequence: Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction, Nicotine Content. Receives: Behavioral: Market Price Condition (control); Behavioral: Tobacco Parity Tax Condition; Behavioral: Nicotine-Content Tax Condition; Behavioral: Harm-Reduction Tax Condition; Behavioral: Modified Risk Tobacco Product (MRTP) Tax Condition |
| Cigarette smokers - Sequence 2 | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the four tax policy conditions in this sequence: Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction. Receives: Behavioral: Market Price Condition (control); Behavioral: Tobacco Parity Tax Condition; Behavioral: Nicotine-Content Tax Condition; Behavioral: Harm-Reduction Tax Condition; Behavioral: Modified Risk Tobacco Product (MRTP) Tax Condition |
| Cigarette smokers - Sequence 3 | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Modified Risk Tobacco Products, Harm Reduction, Nicotine Content, Tobacco Parity. Receives: Behavioral: Market Price Condition (control); Behavioral: Tobacco Parity Tax Condition; Behavioral: Nicotine-Content Tax Condition; Behavioral: Harm-Reduction Tax Condition; Behavioral: Modified Risk Tobacco Product (MRTP) Tax Condition |
| Cigarette smokers - Sequence 4 | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Harm Reduction, Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products. Receives: Behavioral: Market Price Condition (control); Behavioral: Tobacco Parity Tax Condition; Behavioral: Nicotine-Content Tax Condition; Behavioral: Harm-Reduction Tax Condition; Behavioral: Modified Risk Tobacco Product (MRTP) Tax Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Tobacco Products Purchased in the High-Tax Tier - Product demand (intensity and elasticity)
Purchasing of high-tax tier products in the ETM conditions will be fit to a commonly used exponential demand model that quantifies the relationship between the multiplicative tax factor (e.g., 2 times base tax rate) and purchasing of high-tax tier products. This demand analysis (which assumes a negative association between price and purchasing) will be used in the high-tax tier products because participants will be conventional cigarette smokers and these products (when available) will always be in that tier. As such, we expect participants to defend their purchase of cigarettes in the high-tax tier under a variety of conditions. Demand estimates will be obtained for each participant in each tax proposal.
Measured: 1 day
Quantity of Tobacco Products Purchased in the Medium- and No-tax tiers - Product substitution (intensity and slope)
Purchasing of medium- and no-tax products in the ETM conditions will be fit to ordinary least squares regression for each tax tier. This yields slope measures of each tax tier's product purchasing, wherein more positive slopes indicate greater substitution (i.e., greater increases in purchasing of substitutes as tax magnitudes increase). Ordinary least squares regression is used here to model purchasing in the medium- and no-tax tier because it is capable of measuring positive slopes, indicative of substitution, and distinguishing these tiers from those that do not show substitution. In the event this relationship is non-linear, we will consider other relevant models.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 Apr 2023
- Primary completion27 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Crossover
- Model description
- Participants will each complete two control trials and four Experimental Marketplace conditions, representing each of the four tax proposals. The order of tax proposal conditions will be determined randomly. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Roswell Park Cancer Institute
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Jeff S Stein, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTCChristine E Sheffer, Ph.D., Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370313
- Sponsor's protocol ID
- VT IRB # 22-433
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team will share de-identified data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETM Taxes Study 1: The Impact of Innovative Tax Proposals on Purchase Patterns
- ClinicalTrials.gov ID
- NCT05370313
- Acronym / sponsor ID
- VT IRB # 22-433
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Roswell Park Cancer Institute
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 11 May 2022 (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.
This study will investigate the effect of four tax proposals (i.e. Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) on tobacco product purchasing patterns.
Detailed description
This study experimentally examines the effects of largely untried integrated tax proposals. Four tax proposals will be modeled: Tobacco Parity, Nicotine-Content, Harm-Reduction, and MRTP. Tobacco products are placed into three tax tiers: high-, medium-, and no-tax, according to the goals of each proposal. In a within-subjects design, cigarette smokers will complete two control (market price) trials and four conditions in the Experimental Tobacco Marketplace, representing each of the four tax proposals. Within each condition, taxes will be increased proportionally across 5 trials (relative to tax tier) to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will each complete two control trials and four Experimental Marketplace conditions, representing each of the four tax proposals. The order of tax proposal conditions will be determined randomly. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
| Arm | Type | Receives |
|---|---|---|
| Cigarette smokers - Sequence 1 | Experimental | Behavioral: Market Price Condition (control), Behavioral: Tobacco Parity Tax Condition, Behavioral: Nicotine-Content Tax Condition, Behavioral: Harm-Reduction Tax Condition, Behavioral: Modified Risk Tobacco Product (MRTP) Tax ConditionExclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the four tax policy conditions in this sequence: Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction, Nicotine Content. |
| Cigarette smokers - Sequence 2 | Experimental | Behavioral: Market Price Condition (control), Behavioral: Tobacco Parity Tax Condition, Behavioral: Nicotine-Content Tax Condition, Behavioral: Harm-Reduction Tax Condition, Behavioral: Modified Risk Tobacco Product (MRTP) Tax ConditionExclusive cigarette smokers will be recruited and will be exposed to two control trials and the four tax policy conditions in this sequence: Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction. |
| Cigarette smokers - Sequence 3 | Experimental | Behavioral: Market Price Condition (control), Behavioral: Tobacco Parity Tax Condition, Behavioral: Nicotine-Content Tax Condition, Behavioral: Harm-Reduction Tax Condition, Behavioral: Modified Risk Tobacco Product (MRTP) Tax ConditionExclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Modified Risk Tobacco Products, Harm Reduction, Nicotine Content, Tobacco Parity. |
| Cigarette smokers - Sequence 4 | Experimental | Behavioral: Market Price Condition (control), Behavioral: Tobacco Parity Tax Condition, Behavioral: Nicotine-Content Tax Condition, Behavioral: Harm-Reduction Tax Condition, Behavioral: Modified Risk Tobacco Product (MRTP) Tax ConditionExclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Harm Reduction, Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- provide informed consent
- provide a breath carbon monoxide sample ≥ 8 ppm,
- be at least 21 years of age (the legal age to purchase tobacco),
- smoke at least 10 cigarettes daily, and
- use other tobacco products less than weekly.
Key exclusion criteria (5 listed)
- report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
- use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
- report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
- be pregnant or lactating, or
- have plans to move out of the area during the experiment.
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 |
|---|---|---|
| Market Price Condition (control)Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Cigarette taxes increased across trials at the same magnitudes used in the tax conditions. | Behavioural | Cigarette smokers - Sequence 1, Cigarette smokers - Sequence 2, Cigarette smokers - Sequence 3, Cigarette smokers - Sequence 4 |
| Tobacco Parity Tax ConditionTobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all tobacco products are placed in the high-tax tier while products that do not contain tobacco (e.g., herbal cigarettes and nicotine-free ENDS) are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier. | Behavioural | Cigarette smokers - Sequence 1, Cigarette smokers - Sequence 2, Cigarette smokers - Sequence 3, Cigarette smokers - Sequence 4 |
| Nicotine-Content Tax ConditionTobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, products with greater than 3 mg nicotine per single unit are placed in the high-tax tier, products with 0.6-3.0 mg/unit in the medium-tax tier, and those with 0.5 mg/unit or less in the no-tax tier. | Behavioural | Cigarette smokers - Sequence 1, Cigarette smokers - Sequence 2, Cigarette smokers - Sequence 3, Cigarette smokers - Sequence 4 |
| Harm-Reduction Tax ConditionTobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all combustible products with high abuse liability are placed in the high-tax tier. All non-combustible products or combustible products with low abuse liability are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier. | Behavioural | Cigarette smokers - Sequence 1, Cigarette smokers - Sequence 2, Cigarette smokers - Sequence 3, Cigarette smokers - Sequence 4 |
| Modified Risk Tobacco Product (MRTP) Tax ConditionTobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all non-MRTP tobacco products are placed in the high-tax tier, MRTPs are placed in the medium-tax tier, and Nicotine Replacement Therapy products are placed in the no-tax tier. | Behavioural | Cigarette smokers - Sequence 1, Cigarette smokers - Sequence 2, Cigarette smokers - Sequence 3, Cigarette smokers - Sequence 4 |
Primary outcome
Quantity of Tobacco Products Purchased in the High-Tax Tier - Product demand (intensity and elasticity)
Time frame: 1 day
Purchasing of high-tax tier products in the ETM conditions will be fit to a commonly used exponential demand model that quantifies the relationship between the multiplicative tax factor (e.g., 2 times base tax rate) and purchasing of high-tax tier products. This demand analysis (which assumes a negative association between price and purchasing) will be used in the high-tax tier products because participants will be conventional cigarette smokers and these products (when available) will always be in that tier. As such, we expect participants to defend their purchase of cigarettes in the high-tax tier under a variety of conditions. Demand estimates will be obtained for each participant in each tax proposal.
Quantity of Tobacco Products Purchased in the Medium- and No-tax tiers - Product substitution (intensity and slope)
Time frame: 1 day
Purchasing of medium- and no-tax products in the ETM conditions will be fit to ordinary least squares regression for each tax tier. This yields slope measures of each tax tier's product purchasing, wherein more positive slopes indicate greater substitution (i.e., greater increases in purchasing of substitutes as tax magnitudes increase). Ordinary least squares regression is used here to model purchasing in the medium- and no-tax tier because it is capable of measuring positive slopes, indicative of substitution, and distinguishing these tiers from those that do not show substitution. In the event this relationship is non-linear, we will consider other relevant models.
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 18 Sep 2025.
- Individual participant dataSharing planned: No. The study team will share de-identified data upon request.
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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 S Stein, Ph.D. principal investigator
Fralin Biomedical Research Institute at VTC
Christine E Sheffer, Ph.D. principal investigator
Roswell Park Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Parity Tax Condition, Nicotine-Content Tax Condition and Harm-Reduction Tax Condition in people with Cigarette Smoking, run by Virginia Polytechnic Institute and State University at 2 sites 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 5 inclusion and 5 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quantity of Tobacco Products Purchased in the High-Tax Tier - Product demand (intensity and elasticity) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.