Tobacco UseNCT06988371
Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace
A study testing Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products and Restriction on characterizing flavors in noncombustible nicotine products in people with Tobacco Use and Cigarette Use, run by Bethany Shorey Fennell, PhD at 1 site in United States.
Trial summary
The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Cigarette Use
- What is being tested?
- Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products and Restriction on characterizing flavors in noncombustible nicotine products
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 747 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 24 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Consume cigarettes 4-30 days per month
- Have no plans to quit nicotine/tobacco products
- Read and understand English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.
Read the detailed description
After granting informed consent, participants will complete the single assessment.
First, investigators will collect information from participants on personal characteristics, substance use patterns and addiction severity, and behavioral and cognitive tasks that measure components of our behavioral economic model of product valuation.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in a realistic tobacco/nicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access a simulated online tobacco marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of tobacco products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine/tobacco products, a procedure our team has shown to generate realistic results. Participants will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
- Conditions
- Tobacco Use, Cigarette Use
- Being tested
- Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products, Restriction on characterizing flavors in noncombustible nicotine products
- Keywords
- tobacco, cigarettes, nondaily smoking, behavioral economics
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced nicotine regulatory environmentBehavioural
In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette.
Restriction on characterizing flavors in combustible nicotine productsBehavioural
In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available.
Restriction on characterizing flavors in noncombustible nicotine productsBehavioural
In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available.
| Study group | Role | What they receive |
|---|---|---|
| Daily smoking | Experimental | Participants who smoke cigarettes every day Receives: Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products |
| Nondaily smoking | Experimental | Participants who smoke cigarettes some days but not every day in a month Receives: Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate behavioral economic demand across all participants under the proposed regulatory environments
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.
Measured: Baseline
Aggregate behavioral economic substitution across all participants under the proposed regulatory environments
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.
Measured: Baseline
Secondary outcomes (2)
Hypothetical quantity purchased in purchase tasks
Measures valuation by assessing hypothetical consumption across a price range and across the range of products used by participants in the past 60 days.
Measured: Baseline
Delay Discounting Tasks
Assesses valuation for future money and nicotine products.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start18 Aug 2025
- Primary completion24 Aug 2026
- Study completion24 Aug 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed crossover-factorial
- Masking
- None (open label)
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bethany Shorey Fennell, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Bethany Shorey Fennell, PhD, University of Kentucky
- Investigators
- Bethany Shorey Fennell, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988371
- Sponsor's protocol ID
- 99596
- Other IDs
- 5U54DA058256-02
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace
- ClinicalTrials.gov ID
- NCT06988371
- Acronym / sponsor ID
- 99596
- Conditions
- Tobacco Use, Cigarette Use
- Keywords
- tobacco, cigarettes, nondaily smoking, behavioral economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Bethany Shorey Fennell, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 23 May 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.
The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.
Detailed description
After granting informed consent, participants will complete the single assessment.
First, investigators will collect information from participants on personal characteristics, substance use patterns and addiction severity, and behavioral and cognitive tasks that measure components of our behavioral economic model of product valuation.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in a realistic tobacco/nicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access a simulated online tobacco marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of tobacco products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine/tobacco products, a procedure our team has shown to generate realistic results. Participants will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed crossover-factorial
| Arm | Type | Receives |
|---|---|---|
| Daily smoking | Experimental | Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who smoke cigarettes every day |
| Nondaily smoking | Experimental | Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who smoke cigarettes some days but not every day in a month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Consume cigarettes 4-30 days per month
- Have no plans to quit nicotine/tobacco products
- Read and understand English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reduced nicotine regulatory environmentIn this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette. | Behavioural | Daily smoking, Nondaily smoking |
| Restriction on characterizing flavors in combustible nicotine productsIn this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available. | Behavioural | Daily smoking, Nondaily smoking |
| Restriction on characterizing flavors in noncombustible nicotine productsIn this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available. | Behavioural | Daily smoking, Nondaily smoking |
Primary outcome
Aggregate behavioral economic demand across all participants under the proposed regulatory environments
Time frame: Baseline
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.
Aggregate behavioral economic substitution across all participants under the proposed regulatory environments
Time frame: Baseline
Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.
2 secondary outcomes
Hypothetical quantity purchased in purchase tasks
Time frame: Baseline
Delay Discounting Tasks
Time frame: Baseline
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 Sep 2026.
- Individual participant dataSharing planned: No. Only deidentified data will 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.
Bethany Shorey Fennell, 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 Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products and Restriction on characterizing flavors in noncombustible nicotine products in people with Tobacco Use and Cigarette Use, run by Bethany Shorey Fennell, 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 4 inclusion and 0 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 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 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?
Aggregate behavioral economic demand across all participants under the proposed regulatory environments (time frame: Baseline). 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 1 Sep 2026.