Cigarette Smoking BehaviorNCT07042373
Effects of Tobacco Abuse Liability-dependent Taxes in the ETM
A study testing Product Category Score, Product Category Rank and Product Tiers in people with Cigarette Smoking Behavior, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Product Category Score, Product Category Rank and Product Tiers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 7 Apr 2027
- 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
- Be at least 21 years of age or older
- Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
- Smoke at least 10 cigarettes daily
- Use other tobacco products less than weekly
Who cannot join
- Have uncontrolled physical or mental health conditions
- 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
- If they are pregnant or lactating
- Have plans to move out of the area during the experiment
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Innovative Policy: Effects of Tobacco Abuse Liability-dependent Taxes in the ETM
In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution.
The investigators will use a repeated-measures (within subject) analysis of variance (ANOVA) to test if there are differences between conditions (i.e., tax proposals) independently for each product. The models will include study design parameters for order effects to account for counterbalancing the tax conditions in the ETM. Each tax condition will be compared to the control. All distributional assumptions will be checked prior to analyses and the appropriate transformations will be employed, if needed. For each significant result from the omnibus test, the investigators will perform planned contrasts to test the proposed hypotheses previously described. Note that the omnibus test can result in a significant finding while the contrasts of interest may be non-significant. In this case, the investigators will only report the results from the planned contrasts.
Additional analyses might be conducted.
Read the detailed description
In this study, the investigators will experimentally examine the impact of abuse-liability taxes on tobacco product purchases and ultimately tobacco dependence.
The investigators hypothesize that (1) the three abuse-liability tax proposals (product category score; product category rank; product tiers) will decrease purchasing of products with the highest abuse liability; and (2) increase purchasing of products with lower abuse liability (substitution) compared to control. Moreover, (3) the tax rate based on product category score will lead to the greatest substitution, because it is most reflective of abuse liability differences.
In a within-subject design, cigarette smokers stratified by age will complete one control trial and three ETM conditions representing the three tax rates based on abuse liability. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing and substitution are affected.
The study will consist of two in-lab visits and one phone call visit: 1) a consent and assessments session 2) an ETM session, and a 3) follow-up phone-call session approximately 7 days after session 2. Session 1 and 2 will be separated by an at home product sampling phase.
- Session 1: Consent and Assessments In the consent and initial assessment session, participants will go through standard consent procedures. Participants will provide a breath sample to confirm recent levels of smoking that will be measured using a CoVita® Micro+ Basic Smokelizer. Women of child-bearing age will provide a urine sample to test for pregnancy. Participants will complete a timeline follow back to assess previous month smoking habits and consumption of nicotine products to determine ETM budget. Participants will complete a survey with demographic questions and nicotine/tobacco-related assessments (Fagerstrom Test for Cigarette Dependence, Perceived Health Risk adapted, Questionnaire on Smoking Urges-Brief, Motivation to Quit, Self-efficacy to Quit, and The Contemplation Ladder adapted). For the at home sampling period, participants will be shown a menu of the products available for purchase in the ETM. Participants will choose one product from each category, to sample at home, before the next session (approximately 4 days later). Participants will receive instructions to use the products over the next four days. Participants will complete a product evaluation scale for each product. Participants will be asked if they sampled each product as instructed.
- Session 2: ETM In the ETM session, participants will be provided with an individual 7-day experimental budget calculated based on their average tobacco/nicotine consumption over the past 30 days. For example, if a participant reports smoking 20 cigarettes per day (a pack), they will receive $35.00, equivalent to 140 cigarettes (or 7 packs) multiplied by $0.25 per cigarette (market price of an individual cigarette) to spend in the ETM. In the ETM, first, participants will experience two practice trials. Then, participants will complete the real ETM consisting of one control trial and three tax rate conditions based on abuse liability. Conditions will be balanced in a latin square design to account for any other effects. Participants will complete a total of 20 purchasing trials each for 7 days worth of products. In each trial, participants will buy tobacco products to use throughout the next 7 days. At the end of the session, the participant will randomly draw an individual purchasing trial and will receive all the products purchased at that trial to use over the next week. During the following 7 days, the participant is asked to use only the tobacco/nicotine products received during the study.
- Session 3: Follow-up In the follow-up session, participants will receive a phone call from study personnel who will complete a timeline follow back interview to assess previous week recent smoking, and consumption of nicotine products, Product Evaluation Scale, Motivation to Quit, Self-efficacy to quit, The Contemplation Ladder adapted, and Experiment/Experimenter Attitudes Rating Scale. These questions may be asked over the phone and/or using zoom.
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Control, Product Category Score, Product Category Rank, Product Tiers
- Keywords
- Cigarettes, Experimental Tobacco Marketplace, Abuse Liability
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
In the control condition, participants will purchase tobacco/nicotine products in the ETM. Cigarettes will increase in price across trials.
Product Category ScoreBehavioural
In the product category score condition, participants will purchase tobacco/nicotine products in the ETM where the percentage of taxes applied to each product category will be distributed between 0% and 100% proportional to their abuse liability score. Abuse liability scores will be scaled such that the product category with the highest abuse liability will be taxed at 100%.
Product Category RankBehavioural
In the product category rank condition, participants will purchase tobacco/nicotine products in the ETM where the tax percentage applied to each product category will be determined by the number of categories and their position in the ranking. The product category with the highest abuse liability will be taxed at 100%; the product with the lowest abuse liability will be taxed at 0%. All other tax rates will be equally spaced across other products based on ranking.
Product TiersBehavioural
In the product tiers condition, participants will purchase tobacco/nicotine products in the ETM where tobacco products will be placed in tax tiers to simplify the existing complex tobacco tax system. The investigators will use three tax tiers (i.e., high tax, medium tax, and no tax), as adopted by four states. Products will be placed into tiers depending on their average score (i.e. no tax: < 0.33, medium tax: 0.33-0.66, and high tax: >0.66). Products in the high tax tier will be taxed at 100% and products in the medium tax tier will be taxed at 50%.
| Study group | Role | What they receive |
|---|---|---|
| Cigarette smokers | Experimental | In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution. Receives: Behavioral: Control; Behavioral: Product Category Score; Behavioral: Product Category Rank; Behavioral: Product Tiers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Demand Intensity
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 * 10^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Intensity will be reported, which represents the estimated mg of nicotine purchased when cigarettes are free (price = 0).
Measured: Day 1
Cigarette Demand Elasticity
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 * 10^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Elasticity will be reported, which represents the sensitivity of purchasing to changes in cigarette price.
Measured: Day 1
Nicotine/Tobacco Products Substitution Slope
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis).
To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Slope of price-constant products will be reported, which represents the change in mg of nicotine purchased of price-constant products divided by the change in cigarette price.
Measured: Day 1
Nicotine/Tobacco Products Substitution Intercept
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Y-intercept of price-constant products will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start31 Jul 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Why it stopped: We submitted to the NIH to change our aim and not do this study, therefore this never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Roberta Freitas Lemos, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042373
- Sponsor's protocol ID
- VT IRB # 23-729
- Other IDs
- 5K01CA279490-02
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographical, behavioral, and ETM data will be stored within a secure computing environment. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Data from this project will be preserved to enable sharing via NDA with sufficient quality to validate and replicate research findings. All data will be provided in .CSV format. Respondent identifiers will not be shared.
Publications
Chaloupka FJ, Grossman M, Bickel WK, Saffer H. The Economic Analysis of Substance Use and Abuse: An Integration of Econometric and Behavioral Economic Research. 1999 Jan 1
Freitas-Lemos R, Keith DR, Tegge AN, Stein JS, Cummings KM, Bickel WK. Estimating the Impact of Tobacco Parity and Harm Reduction Tax Proposals Using the Experimental Tobacco Marketplace. Int J Environ Res Public Health. 2021 Jul 23;18(15):7835. doi: 10.3390/ijerph18157835.
PubMed 34360124Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20.
PubMed 28634710Shakhnovich V. It's Time to Reverse our Thinking: The Reverse Translation Research Paradigm. Clin Transl Sci. 2018 Mar;11(2):98-99. doi: 10.1111/cts.12538. Epub 2018 Feb 9. No abstract available.
PubMed 29423973Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.
PubMed 31350894
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Policy: Effects of Tobacco Abuse Liability-dependent Taxes in the ETM
- ClinicalTrials.gov ID
- NCT07042373
- Acronym / sponsor ID
- VT IRB # 23-729
- Conditions
- Cigarette Smoking Behavior
- Keywords
- Cigarettes, Experimental Tobacco Marketplace, Abuse Liability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We submitted to the NIH to change our aim and not do this study, therefore this never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 29 Jun 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, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution.
The investigators will use a repeated-measures (within subject) analysis of variance (ANOVA) to test if there are differences between conditions (i.e., tax proposals) independently for each product. The models will include study design parameters for order effects to account for counterbalancing the tax conditions in the ETM. Each tax condition will be compared to the control. All distributional assumptions will be checked prior to analyses and the appropriate transformations will be employed, if needed. For each significant result from the omnibus test, the investigators will perform planned contrasts to test the proposed hypotheses previously described. Note that the omnibus test can result in a significant finding while the contrasts of interest may be non-significant. In this case, the investigators will only report the results from the planned contrasts.
Additional analyses might be conducted.
Detailed description
In this study, the investigators will experimentally examine the impact of abuse-liability taxes on tobacco product purchases and ultimately tobacco dependence.
The investigators hypothesize that (1) the three abuse-liability tax proposals (product category score; product category rank; product tiers) will decrease purchasing of products with the highest abuse liability; and (2) increase purchasing of products with lower abuse liability (substitution) compared to control. Moreover, (3) the tax rate based on product category score will lead to the greatest substitution, because it is most reflective of abuse liability differences.
In a within-subject design, cigarette smokers stratified by age will complete one control trial and three ETM conditions representing the three tax rates based on abuse liability. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing and substitution are affected.
The study will consist of two in-lab visits and one phone call visit: 1) a consent and assessments session 2) an ETM session, and a 3) follow-up phone-call session approximately 7 days after session 2. Session 1 and 2 will be separated by an at home product sampling phase.
- Session 1: Consent and Assessments In the consent and initial assessment session, participants will go through standard consent procedures. Participants will provide a breath sample to confirm recent levels of smoking that will be measured using a CoVita® Micro+ Basic Smokelizer. Women of child-bearing age will provide a urine sample to test for pregnancy. Participants will complete a timeline follow back to assess previous month smoking habits and consumption of nicotine products to determine ETM budget. Participants will complete a survey with demographic questions and nicotine/tobacco-related assessments (Fagerstrom Test for Cigarette Dependence, Perceived Health Risk adapted, Questionnaire on Smoking Urges-Brief, Motivation to Quit, Self-efficacy to Quit, and The Contemplation Ladder adapted). For the at home sampling period, participants will be shown a menu of the products available for purchase in the ETM. Participants will choose one product from each category, to sample at home, before the next session (approximately 4 days later). Participants will receive instructions to use the products over the next four days. Participants will complete a product evaluation scale for each product. Participants will be asked if they sampled each product as instructed.
- Session 2: ETM In the ETM session, participants will be provided with an individual 7-day experimental budget calculated based on their average tobacco/nicotine consumption over the past 30 days. For example, if a participant reports smoking 20 cigarettes per day (a pack), they will receive $35.00, equivalent to 140 cigarettes (or 7 packs) multiplied by $0.25 per cigarette (market price of an individual cigarette) to spend in the ETM. In the ETM, first, participants will experience two practice trials. Then, participants will complete the real ETM consisting of one control trial and three tax rate conditions based on abuse liability. Conditions will be balanced in a latin square design to account for any other effects. Participants will complete a total of 20 purchasing trials each for 7 days worth of products. In each trial, participants will buy tobacco products to use throughout the next 7 days. At the end of the session, the participant will randomly draw an individual purchasing trial and will receive all the products purchased at that trial to use over the next week. During the following 7 days, the participant is asked to use only the tobacco/nicotine products received during the study.
- Session 3: Follow-up In the follow-up session, participants will receive a phone call from study personnel who will complete a timeline follow back interview to assess previous week recent smoking, and consumption of nicotine products, Product Evaluation Scale, Motivation to Quit, Self-efficacy to quit, The Contemplation Ladder adapted, and Experiment/Experimenter Attitudes Rating Scale. These questions may be asked over the phone and/or using zoom.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cigarette smokers | Experimental | Behavioral: Control, Behavioral: Product Category Score, Behavioral: Product Category Rank, Behavioral: Product TiersIn a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution. |
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
- Be at least 21 years of age or older
- Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
- Smoke at least 10 cigarettes daily
- Use other tobacco products less than weekly
Key exclusion criteria (5 listed)
- Have uncontrolled physical or mental health conditions
- 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
- If they are pregnant or lactating
- 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 |
|---|---|---|
| ControlIn the control condition, participants will purchase tobacco/nicotine products in the ETM. Cigarettes will increase in price across trials. | Behavioural | Cigarette smokers |
| Product Category ScoreIn the product category score condition, participants will purchase tobacco/nicotine products in the ETM where the percentage of taxes applied to each product category will be distributed between 0% and 100% proportional to their abuse liability score. Abuse liability scores will be scaled such that the product category with the highest abuse liability will be taxed at 100%. | Behavioural | Cigarette smokers |
| Product Category RankIn the product category rank condition, participants will purchase tobacco/nicotine products in the ETM where the tax percentage applied to each product category will be determined by the number of categories and their position in the ranking. The product category with the highest abuse liability will be taxed at 100%; the product with the lowest abuse liability will be taxed at 0%. All other tax rates will be equally spaced across other products based on ranking. | Behavioural | Cigarette smokers |
| Product TiersIn the product tiers condition, participants will purchase tobacco/nicotine products in the ETM where tobacco products will be placed in tax tiers to simplify the existing complex tobacco tax system. The investigators will use three tax tiers (i.e., high tax, medium tax, and no tax), as adopted by four states. Products will be placed into tiers depending on their average score (i.e. no tax: < 0.33, medium tax: 0.33-0.66, and high tax: >0.66). Products in the high tax tier will be taxed at 100% and products in the medium tax tier will be taxed at 50%. | Behavioural | Cigarette smokers |
Primary outcome
Cigarette Demand Intensity
Time frame: Day 1
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 * 10^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Intensity will be reported, which represents the estimated mg of nicotine purchased when cigarettes are free (price = 0).
Cigarette Demand Elasticity
Time frame: Day 1
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 * 10^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Elasticity will be reported, which represents the sensitivity of purchasing to changes in cigarette price.
Nicotine/Tobacco Products Substitution Slope
Time frame: Day 1
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Slope of price-constant products will be reported, which represents the change in mg of nicotine purchased of price-constant products divided by the change in cigarette price.
Nicotine/Tobacco Products Substitution Intercept
Time frame: Day 1
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Y-intercept of price-constant products will be reported.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- BackgroundChaloupka FJ, Grossman M, Bickel WK, Saffer H. The Economic Analysis of Substance Use and Abuse: An Integration of Econometric and Behavioral Economic Research. 1999 Jan 1
- Background: PubMed 34360124Freitas-Lemos R, Keith DR, Tegge AN, Stein JS, Cummings KM, Bickel WK. Estimating the Impact of Tobacco Parity and Harm Reduction Tax Proposals Using the Experimental Tobacco Marketplace. Int J Environ Res Public Health. 2021 Jul 23;18(15):7835. doi: 10.3390/ijerph18157835.
- Background: PubMed 28634710Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20.
- Background: PubMed 29423973Shakhnovich V. It's Time to Reverse our Thinking: The Reverse Translation Research Paradigm. Clin Transl Sci. 2018 Mar;11(2):98-99. doi: 10.1111/cts.12538. Epub 2018 Feb 9. No abstract available.
- Background: PubMed 31350894Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.
- Individual participant dataSharing planned: Yes. Demographical, behavioral, and ETM data will be stored within a secure computing environment. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Data from this project will be preserved to enable sharing via NDA with sufficient quality to validate and replicate research findings. All data will be provided in .CSV format. Respondent identifiers will not be shared.
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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.
Roberta Freitas Lemos, Ph.D. principal investigator
Fralin Biomedical Research Institute at VTC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product Category Score, Product Category Rank and Product Tiers in people with Cigarette Smoking Behavior, 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 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: withdrawn, as of the sponsor's last update on 15 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Cigarette Demand Intensity (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT07042373, which also lists 5 linked publications.
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 15 Sep 2026.