Alcohol UseNCT07010601
Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use
A study testing Experimental Tobacco Marketplace and Hypothetical Novel Nicotine Product Purchase Tasks in people with Alcohol Use and E-cigarette Use, run by Mark J Rzeszutek, PhD at 1 site in United States.
Trial summary
A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, E-cigarette Use, Cigarette Use
- What is being tested?
- Experimental Tobacco Marketplace and Hypothetical Novel Nicotine Product Purchase Tasks
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- Smoke cigarettes or use e-cigarettes 25 or more days a month
- Cigarette/E-Cigarette Non-Users
- 21 years of age or older
- Do not report using an e-cigarette or cigarette in the past month
- Risky Alcohol Users
Show all 14Show fewer
- 21 years of age or older
- A score of 8 or higher on the Alcohol Use Disorder Identification Test
- Non-Risky Alcohol Users
- 21 years of age or older
- A score of 7 or lower on the Alcohol Use Disorder Identification Test
- All groups
- Located in the USA
- At least 100 complete studies on Prolific
Who cannot join
- Failing attention checks during the screener
Trial locations and contacts
1 site in 1 country.
About this study
Official title: U54 Pilot: Comparing Tobacco Product Susceptibility and Product Substitution by Relative Rurality and Alcohol Use
A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.
- Conditions
- Alcohol Use, E-cigarette Use, Cigarette Use
- Being tested
- Experimental Tobacco Marketplace, Hypothetical Novel Nicotine Product Purchase Tasks
- Medical subject headings
- Alcohol Drinking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Tobacco MarketplaceBehavioural
This study will have three different scenarios in the Experimental Tobacco Marketplace (ETM) for participants who reported being cigarette and/or e-cigarette users. These will consist of hypothetical purchase scenarios where a variety of different tobacco products are available to purchase. The three ETM scenarios will be adjusting price cigarettes, adjusting price e-cigarettes, and both adjusting price cigarettes and e-cigarettes.
Hypothetical Novel Nicotine Product Purchase TasksBehavioural
This study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points.
| Study group | Role | What they receive |
|---|---|---|
| Low Alcohol Use + No Cigarette/E-Cigarette Use | Experimental | Participants with low alcohol use and no cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks Receives: Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks |
| High Alcohol Use + No Cigarette/E-Cigarette Use | Experimental | Participants with high alcohol use and no cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks. Receives: Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks |
| Low Alcohol Use + Cigarette/E-Cigarette Use | Experimental | Participants with low alcohol use and cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price. Receives: Behavioral: Experimental Tobacco Marketplace; Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks |
| High Alcohol Use + Cigarette/E-Cigarette Use | Experimental | Participants with high alcohol use and cigarette or e-cigarette usewill complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price. Receives: Behavioral: Experimental Tobacco Marketplace; Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand Intensity for Hypothetical Nicotine Products
Demand intensity was assessed using hypothetical purchase tasks in which participants reported the number of products they would purchase at varying prices. In this case, demand intensity refers to the likelihood to try/consume a novel nicotine product when then cost of that product was free (i.e., likelihood to try at $0 ranging from 0-100).
Measured: Baseline (study week 0) During the Hypothetical Purchase Task
Price Sensitivity for Hypothetical Nicotine Products
Demand sensitivity to novel hypothetical products was assessed for flavor, nicotine, and product type. Sensitivity was measured by finding the highest likelihood times cost per participant per condition, or the maximum likelihood expenditure (also referred to as Omax). Based on the task used, values can range from 0-5000.
Measured: Baseline (study week 0) During the Hypothetical Purchase Task
Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace
Cigarette and e-cigarette users completed three different experimental tobacco marketplaces. They each completed a marketplace where e-cigarettes adjusted in price, another where cigarettes adjusted in price, and a third where both cigarettes and e-cigarettes adjusted in price. Then substitution for different product categories was assessed by the difference in amount spent in USD at the lowest price of the adjusting product to the highest price of the adjusting product. Positive values indicate an increase in consumption as a function of increasing cost of the adjusting price product (i.e., substitution).
Measured: Baseline (study week 0) During the Hypothetical Purchase Task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start18 Aug 2025
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol UseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark J Rzeszutek, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Mark J Rzeszutek, PhD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010601
- Sponsor's protocol ID
- 5U54DA058256-02 Pilot: #2345
- Other IDs
- 5U54DA058256-02
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from this study will be made as available as possible after acceptance for publication. All shared data will comply with HIPAA guidelines on personally identifiable information. Code used for analyses will also accompany deidentified data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U54 Pilot: Comparing Tobacco Product Susceptibility and Product Substitution by Relative Rurality and Alcohol Use
- ClinicalTrials.gov ID
- NCT07010601
- Acronym / sponsor ID
- 5U54DA058256-02 Pilot: #2345
- Conditions
- Alcohol Use, E-cigarette Use, Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Mark J Rzeszutek, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Alcohol Use + No Cigarette/E-Cigarette Use | Experimental | Behavioral: Hypothetical Novel Nicotine Product Purchase TasksParticipants with low alcohol use and no cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks |
| High Alcohol Use + No Cigarette/E-Cigarette Use | Experimental | Behavioral: Hypothetical Novel Nicotine Product Purchase TasksParticipants with high alcohol use and no cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks. |
| Low Alcohol Use + Cigarette/E-Cigarette Use | Experimental | Behavioral: Experimental Tobacco Marketplace, Behavioral: Hypothetical Novel Nicotine Product Purchase TasksParticipants with low alcohol use and cigarette or e-cigarette use will complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price. |
| High Alcohol Use + Cigarette/E-Cigarette Use | Experimental | Behavioral: Experimental Tobacco Marketplace, Behavioral: Hypothetical Novel Nicotine Product Purchase TasksParticipants with high alcohol use and cigarette or e-cigarette usewill complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 21 years of age or older
- Smoke cigarettes or use e-cigarettes 25 or more days a month
- Cigarette/E-Cigarette Non-Users
- 21 years of age or older
- Do not report using an e-cigarette or cigarette in the past month
Key exclusion criteria (1 listed)
- Failing attention checks during the screener
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 |
|---|---|---|
| Experimental Tobacco MarketplaceThis study will have three different scenarios in the Experimental Tobacco Marketplace (ETM) for participants who reported being cigarette and/or e-cigarette users. These will consist of hypothetical purchase scenarios where a variety of different tobacco products are available to purchase. The three ETM scenarios will be adjusting price cigarettes, adjusting price e-cigarettes, and both adjusting price cigarettes and e-cigarettes. | Behavioural | High Alcohol Use + Cigarette/E-Cigarette Use, Low Alcohol Use + Cigarette/E-Cigarette Use |
| Hypothetical Novel Nicotine Product Purchase TasksThis study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points. | Behavioural | High Alcohol Use + Cigarette/E-Cigarette Use, High Alcohol Use + No Cigarette/E-Cigarette Use, Low Alcohol Use + Cigarette/E-Cigarette Use, Low Alcohol Use + No Cigarette/E-Cigarette Use |
Primary outcome
Demand Intensity for Hypothetical Nicotine Products
Time frame: Baseline (study week 0) During the Hypothetical Purchase Task
Demand intensity was assessed using hypothetical purchase tasks in which participants reported the number of products they would purchase at varying prices. In this case, demand intensity refers to the likelihood to try/consume a novel nicotine product when then cost of that product was free (i.e., likelihood to try at $0 ranging from 0-100).
Price Sensitivity for Hypothetical Nicotine Products
Time frame: Baseline (study week 0) During the Hypothetical Purchase Task
Demand sensitivity to novel hypothetical products was assessed for flavor, nicotine, and product type. Sensitivity was measured by finding the highest likelihood times cost per participant per condition, or the maximum likelihood expenditure (also referred to as Omax). Based on the task used, values can range from 0-5000.
Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace
Time frame: Baseline (study week 0) During the Hypothetical Purchase Task
Cigarette and e-cigarette users completed three different experimental tobacco marketplaces. They each completed a marketplace where e-cigarettes adjusted in price, another where cigarettes adjusted in price, and a third where both cigarettes and e-cigarettes adjusted in price. Then substitution for different product categories was assessed by the difference in amount spent in USD at the lowest price of the adjusting product to the highest price of the adjusting product. Positive values indicate an increase in consumption as a function of increasing cost of the adjusting price product (i.e., substitution).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data from this study will be made as available as possible after acceptance for publication. All shared data will comply with HIPAA guidelines on personally identifiable information. Code used for analyses will also accompany deidentified data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Tobacco Marketplace and Hypothetical Novel Nicotine Product Purchase Tasks in people with Alcohol Use and E-cigarette Use, run by Mark J Rzeszutek, PhD 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 14 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 15 Oct 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?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Demand Intensity for Hypothetical Nicotine Products (time frame: Baseline (study week 0) During the Hypothetical Purchase Task). The study lists 3 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 15 Oct 2026.