Tobacco UseNCT07213947
Comparison of Demand and Substitution for Nicotine Pouches as a Function of Nicotine Dosage
A study testing Nicotine Pouch Dosage in people with Tobacco Use and Nicotine Pouch Self-Administration, run by William Middleton at 1 site in United States.
Trial summary
Smoking is a prominent public health issue. Traditional nicotine replacement therapy suffers from being a poor substitute for cigarettes. Novel tobacco products, such as nicotine pouches, show promise as potential low-harm substitutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Nicotine Pouch Self-Administration
- What is being tested?
- Nicotine Pouch Dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to 2 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tobacco users will be eligible for a general screener
- nicotine pouch users will be eligible for the full marketplace study
- users of the crowdsourcing website Prolific
Who cannot join
- non nicotine pouch user
- <18+ years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Turfland Medical Center, Department of Family and Community Medicine
Lexington, Kentucky, 40503
About this study
Official title: Demand and Substitution for Nicotine Pouches Across Dosage
Smoking is a prominent public health issue. Traditional nicotine replacement therapy suffers from being a poor substitute for cigarettes. Novel tobacco products, such as nicotine pouches, show promise as potential low-harm substitutes. Investigators wish to assess the substitutability of cigarettes for nicotine pouches at different dosages and price points. This study will consist of 4000 screened participants online on the crowdsourcing software Prolific, with roughly 400 eligible participants. This study will include the use of an electronic tobacco marketplace.
Read the detailed description
Participants will be recruited using the crowdsourcing platform Prolific. Prolific has been used by investigators in the past to rapidly recruit a large number of participants. Prolific is powerful due to its ability to sample for specific participant characteristics, such as rurality, while limiting the number of participants who can falsely qualify for the study. This study will screen 4000 tobacco users. Of these we expect to consent 400 nicotine pouch users to the main study. We will then identify their relative rurality through the index of relative rurality.
All potential participants will complete a series of demographic questions related to tobacco use, exposure to tobacco marketing, behavioral factors, and rurality, which will act as predictors of susceptibility to nicotine pouch initiation. All participants' Zip-code will be sampled and transformed into Index of Relative Rurality scores to assess rurality continuously. Data for nicotine pouch users will be assessed using multivariable regression-based analysis with interactions to determine which factors influence susceptibility to products other than nicotine pouches, and the effect of index of relative rurality on the relationship between predictors and initiation. Nicotine pouch users will continue on to an experimental tobacco marketplace (ETM) that will assess their valuation of nicotine pouches against other tobacco products, which will serve as a proxy to their likelihood to switch from nicotine pouches when the cost required to obtain nicotine pouches increases. Participants will complete 8 scenarios with escalating prices for nicotine pouches. Participants will be exposed to a virtual store and prompted to purchase as many tobacco products as they wish with an unlimited budget for their weekly supply of tobacco products. After making a set of purchases, participants will continue on to a subsequent marketplace where the price of their preferred product is increased. The degree to which participants purchase other tobacco products as nicotine pouch price increases will constitute demand. Demand will be analyzed using multilevel modeling methods to produce relevant demand indices. Participants will then have to complete 5 marketplaces of 8 price conditions. In each marketplace, the nicotine dosage of nicotine pouches will be randomly assigned to either 0 milligrams, 2 milligrams, 4 milligrams, 6 milligrams, or 8 milligrams.
- Conditions
- Tobacco Use, Nicotine Pouch Self-Administration
- Being tested
- Nicotine Pouch Dosage
- Keywords
- nicotine pouch, behavioral economics, substitution, e-cigarettes, nicotine concentration
- Medical subject headings
- Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Pouch DosageOther
All participants will be experimentally manipulated by having nicotine dosage in hypothetical purchase tasks/ experimental marketplaces altered between market groups.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine pouch purchase | Experimental | All participants will be experimentally manipulated by randomizing the dosage of nicotine pouches across varying pricing conditions. Receives: Other: Nicotine Pouch Dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Pouch Demand Indices
Behavioral demand curves will be drawn for nicotine pouch consumption as a function of price. Demand curves will be compared across dosage conditions on three indices: breakpoint (price at which consumption drops to zero) , elasticity of demand (rate of decline of consumption at any price), and intensity of demand (consumption at zero price).
Measured: Within 1 hour of enrollment, participants are expected to have completed the full trial.
Secondary outcomes (2)
Substitution of Nicotine Pouches for other Tobacco Products
The experimental tobacco marketplace will also include a variety of other tobacco products. Investigators will examine whether individuals begin consuming other products as the price of nicotine pouches increases. Examining substitution for combustible and e-cigarettes is a secondary outcome.
Measured: Within 1 hour of enrollment participants are expected to have completed the whole trial.
Effects of Relative Rurality on Nicotine Pouch Demand and Substitution
The Index of Relative Rurality will be used to compare demand for nicotine pouches across dosages and substitution effects across an all encompassing spectrum of rurality to determine whether urbanity, periurbanity, or rurality are risk profiles for harmful tobacco consumption
Measured: Within 1 hour of enrollment participants are expected to have completed the whole trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start4 Dec 2025
- Primary completion2 Jan 2026
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals will be asked to purchase nicotine pouches across various prices. Nicotine pouch dosage will be randomly manipulated across pricing conditions. All participants will experience price and dosage changes, but in different orders.
- Masking
- None (open label)
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Middleton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Middleton, University of Kentucky
- Investigators
- Mikhail Koffarnus, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213947
- Sponsor's protocol ID
- 2372
- Other IDs
- 5U54DA058256-02
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demand and Substitution for Nicotine Pouches Across Dosage
- ClinicalTrials.gov ID
- NCT07213947
- Acronym / sponsor ID
- 2372
- Conditions
- Tobacco Use, Nicotine Pouch Self-Administration
- Keywords
- nicotine pouch, behavioral economics, substitution, e-cigarettes, nicotine concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- William MiddletonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 9 Oct 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.
Smoking is a prominent public health issue. Traditional nicotine replacement therapy suffers from being a poor substitute for cigarettes. Novel tobacco products, such as nicotine pouches, show promise as potential low-harm substitutes. Investigators wish to assess the substitutability of cigarettes for nicotine pouches at different dosages and price points. This study will consist of 4000 screened participants online on the crowdsourcing software Prolific, with roughly 400 eligible participants. This study will include the use of an electronic tobacco marketplace.
Detailed description
Participants will be recruited using the crowdsourcing platform Prolific. Prolific has been used by investigators in the past to rapidly recruit a large number of participants. Prolific is powerful due to its ability to sample for specific participant characteristics, such as rurality, while limiting the number of participants who can falsely qualify for the study. This study will screen 4000 tobacco users. Of these we expect to consent 400 nicotine pouch users to the main study. We will then identify their relative rurality through the index of relative rurality.
All potential participants will complete a series of demographic questions related to tobacco use, exposure to tobacco marketing, behavioral factors, and rurality, which will act as predictors of susceptibility to nicotine pouch initiation. All participants' Zip-code will be sampled and transformed into Index of Relative Rurality scores to assess rurality continuously. Data for nicotine pouch users will be assessed using multivariable regression-based analysis with interactions to determine which factors influence susceptibility to products other than nicotine pouches, and the effect of index of relative rurality on the relationship between predictors and initiation. Nicotine pouch users will continue on to an experimental tobacco marketplace (ETM) that will assess their valuation of nicotine pouches against other tobacco products, which will serve as a proxy to their likelihood to switch from nicotine pouches when the cost required to obtain nicotine pouches increases. Participants will complete 8 scenarios with escalating prices for nicotine pouches. Participants will be exposed to a virtual store and prompted to purchase as many tobacco products as they wish with an unlimited budget for their weekly supply of tobacco products. After making a set of purchases, participants will continue on to a subsequent marketplace where the price of their preferred product is increased. The degree to which participants purchase other tobacco products as nicotine pouch price increases will constitute demand. Demand will be analyzed using multilevel modeling methods to produce relevant demand indices. Participants will then have to complete 5 marketplaces of 8 price conditions. In each marketplace, the nicotine dosage of nicotine pouches will be randomly assigned to either 0 milligrams, 2 milligrams, 4 milligrams, 6 milligrams, or 8 milligrams.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals will be asked to purchase nicotine pouches across various prices. Nicotine pouch dosage will be randomly manipulated across pricing conditions. All participants will experience price and dosage changes, but in different orders.
| Arm | Type | Receives |
|---|---|---|
| Nicotine pouch purchase | Experimental | Other: Nicotine Pouch DosageAll participants will be experimentally manipulated by randomizing the dosage of nicotine pouches across varying pricing conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- tobacco users will be eligible for a general screener
- nicotine pouch users will be eligible for the full marketplace study
- users of the crowdsourcing website Prolific
Key exclusion criteria (2 listed)
- non nicotine pouch user
- <18+ years old
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 |
|---|---|---|
| Nicotine Pouch DosageAll participants will be experimentally manipulated by having nicotine dosage in hypothetical purchase tasks/ experimental marketplaces altered between market groups. | Other | Nicotine pouch purchase |
Primary outcome
Nicotine Pouch Demand Indices
Time frame: Within 1 hour of enrollment, participants are expected to have completed the full trial.
Behavioral demand curves will be drawn for nicotine pouch consumption as a function of price. Demand curves will be compared across dosage conditions on three indices: breakpoint (price at which consumption drops to zero) , elasticity of demand (rate of decline of consumption at any price), and intensity of demand (consumption at zero price).
2 secondary outcomes
Substitution of Nicotine Pouches for other Tobacco Products
Time frame: Within 1 hour of enrollment participants are expected to have completed the whole trial.
Effects of Relative Rurality on Nicotine Pouch Demand and Substitution
Time frame: Within 1 hour of enrollment participants are expected to have completed the whole trial.
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 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Koffarnus, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Pouch Dosage in people with Tobacco Use and Nicotine Pouch Self-Administration, run by William Middleton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 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 1 May 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 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?
Nicotine Pouch Demand Indices (time frame: Within 1 hour of enrollment, participants are expected to have completed the full trial.). 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 1 May 2026.