Cigarette SmokingEarly Phase 1NCT05946031
Testing the ETM: Examination and Comparison of Different Methods
A Early Phase 1 study testing Reat ETM and Hypothetical ETM in people with Cigarette Smoking, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes. 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?
- Reat ETM and Hypothetical ETM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 15 Aug 2025
- Phase
- Early Phase 1
- 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
- Stable tobacco use patterns for at least three months
- Smoke at least 5 cigarettes daily
- Use other tobacco products less than weekly
- Have access to a computer and internet
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: Testing the Experimental Tobacco Marketplace: Examination and Comparison of Different Methods
This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.
Read the detailed description
In a between-group within-subject repeated measures design, participants will be randomly assigned to one of two procedures (in-lab or remote; between-group) and complete two conditions (real and hypothetical; within-subject), which include six trials assessing increasing cigarette prices.
- Conditions
- Cigarette Smoking
- Being tested
- Reat ETM, Hypothetical ETM
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reat ETMDrug
Exclusive cigarette smokers will be recruited and will be exposed to the real ETM condition in which tobacco purchases are real and they receive products from one randomly selected trial.
Hypothetical ETMDrug
Exclusive cigarette smokers will be recruited and will be exposed to the hypothetical ETM condition in which tobacco purchases are hypothetical and they don't receive any products.
| Study group | Role | What they receive |
|---|---|---|
| In-lab procedures | Experimental | Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory. Receives: Drug: Reat ETM; Drug: Hypothetical ETM |
| Remote procedures | Experimental | Exclusive cigarette smokers will be recruited and will experience all study procedures remotely. Receives: Drug: Reat ETM; Drug: Hypothetical ETM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette demand
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will remain constant. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.
Measured: 1 day
Nicotine/tobacco products substitution
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will remain constant. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.
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 posted14 Jul 2023
- Study start2 Dec 2024
- Primary completion14 Aug 2025
- Study completion15 Aug 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete two Experimental Marketplace conditions, representing one with real and one with hypothetical purchasing outcomes. Within each condition, taxes will be increased proportionally across 6 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Jeffrey Stein, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946031
- Sponsor's protocol ID
- IRB #24-837
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Experimental Tobacco Marketplace: Examination and Comparison of Different Methods
- ClinicalTrials.gov ID
- NCT05946031
- Acronym / sponsor ID
- IRB #24-837
- Conditions
- Cigarette Smoking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 14 Jul 2023 (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 experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.
Detailed description
In a between-group within-subject repeated measures design, participants will be randomly assigned to one of two procedures (in-lab or remote; between-group) and complete two conditions (real and hypothetical; within-subject), which include six trials assessing increasing cigarette prices.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete two Experimental Marketplace conditions, representing one with real and one with hypothetical purchasing outcomes. Within each condition, taxes will be increased proportionally across 6 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
| Arm | Type | Receives |
|---|---|---|
| In-lab procedures | Experimental | Drug: Reat ETM, Drug: Hypothetical ETMExclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory. |
| Remote procedures | Experimental | Drug: Reat ETM, Drug: Hypothetical ETMExclusive cigarette smokers will be recruited and will experience all study procedures remotely. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide informed consent
- Be at least 21 years of age or older
- Stable tobacco use patterns for at least three months
- Smoke at least 5 cigarettes daily
- Use other tobacco products less than weekly
Key exclusion criteria (4 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
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 |
|---|---|---|
| Reat ETMExclusive cigarette smokers will be recruited and will be exposed to the real ETM condition in which tobacco purchases are real and they receive products from one randomly selected trial. | Drug | In-lab procedures, Remote procedures |
| Hypothetical ETMExclusive cigarette smokers will be recruited and will be exposed to the hypothetical ETM condition in which tobacco purchases are hypothetical and they don't receive any products. | Drug | In-lab procedures, Remote procedures |
Primary outcome
Cigarette demand
Time frame: 1 day
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will remain constant. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.
Nicotine/tobacco products substitution
Time frame: 1 day
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will remain constant. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.
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 5 Jun 2026.
- 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.
Jeffrey Stein, 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 Early Phase 1 study testing Reat ETM and Hypothetical ETM in people with Cigarette Smoking, 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 6 inclusion and 4 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 5 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cigarette demand (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 5 Jun 2026.