Tobacco UseNCT06234722
Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
A study testing Very Low Nicotine Cigarette, Reduced nicotine regulatory environment and Restriction on characterizing flavors in combustible nicotine products in people with Tobacco Use and Cigarette Use, run by Mikhail N Koffarnus at 1 site in United States.
Trial summary
The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Cigarette Use
- What is being tested?
- Very Low Nicotine Cigarette, Reduced nicotine regulatory environment and Restriction on characterizing flavors in combustible nicotine products
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 21 years old
- Consume nicotine and/or tobacco products daily
- Have no plans to quit nicotine/tobacco consumption or seek treatment in the subsequent 9 weeks
- Read and understand English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 4-week experiment.
Read the detailed description
After granting informed consent, participants will complete a baseline assessment session. This will be followed by an extended 4-week sampling period to acclimate participants to their randomly assigned experimental cigarette and allow any shifts in product consumption patterns to materialize. In the final week of this sampling period, participants will complete behavioral assessments and a series of assessments to assess the impact of potential regulatory environments relevant to our aims.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in our 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 an online marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of 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. Tobacco and nicotine products will match the products found by surveying product availability vendors in the local communities. 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 we have shown to generate realistic results. They will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
Baseline Assessment Session. The first experimental session will be an assessment session to collect information from participants on substance use patterns and addiction severity, as well as the results of behavioral and cognitive tasks that have measure components of our behavioral economic model of product valuation.
Sampling Period. After their assessment session, participants will be given a supply of their randomly assigned reduced-nicotine cigarette corresponding to two weeks of their typical cigarette consumption and asked to use the provided cigarettes as their only combusted tobacco product for 4 consecutive weeks.
- Conditions
- Tobacco Use, Cigarette Use
- Being tested
- Very Low Nicotine Cigarette, Reduced nicotine regulatory environment, Restriction on characterizing flavors in combustible nicotine products, Restriction on characterizing flavors in noncombustible nicotine products
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Nicotine CigaretteDrug
Participants will be assigned to one of two investigational cigarette nicotine levels for the duration of the experiment: 0.4mg/g or 15.8mg/g
Reduced nicotine regulatory environmentBehavioural
In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and only the participants' assigned investigational cigarette 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. Only 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. Only tobacco or no flavored noncombustible nicotine products will be the only noncombustible nicotine products available.
| Study group | Role | What they receive |
|---|---|---|
| Rural - Conventional Cigarette | Placebo comparator | Participants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period. Receives: Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products |
| Peri-Urban - Conventional Cigarette | Placebo comparator | Participants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period. Receives: Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products |
| Peri-Urban - Very Low Nicotine Cigarette | Active comparator | Participants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period. Receives: Drug: Very Low Nicotine Cigarette; Behavioral: Reduced nicotine regulatory environment; Behavioral: Restriction on characterizing flavors in combustible nicotine products; Behavioral: Restriction on characterizing flavors in noncombustible nicotine products |
| Rural - Very Low Nicotine Cigarette | Active comparator | Participants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period. Receives: Drug: Very Low Nicotine Cigarette; 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: Assessed at study week 0 and at study week 4
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: Assessed at study week 0 and at study week 4
Secondary outcomes (11)
Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity
Self-reported marijuana and nicotine product use separated by product type and flavor for the past 60 days.
Measured: Assessed at study week 0 and at study week 4
Fagerström Test for Nicotine Dependence (FTND)
Measure of dependence symptoms, measured on a scale of 0 to 10. A higher score indicates a higher physical dependence on nicotine.
Measured: Assessed at study week 0 and at study week 4
Minnesota Nicotine Withdrawal Scale (MNWS)
Assesses Withdrawal Symptoms. Scored on an ordinal scale ranging from 0 to 3. A higher score indicates increased intensity of symptoms.
Measured: Assessed at study week 0 and at study week 4
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: Assessed at study week 0 and at study week 4
Delay Discounting Tasks
Assesses valuation for future money and nicotine products.
Measured: Assessed at study week 0 and at study week 4
Activity Level Questionnaire - Substance Use Version (ALQ-SUV)
Measures past-month reinforcement from substance-related and substance-free activities, yielding a reinforcement ratio quantifying the proportion of overall reinforcement obtained from nicotine use. The ratio ranges from 0 to 1, with a higher score indicating a greater proportion of reinforcement received from drug-related activities relative to total reinforcement.
Measured: Assessed at study week 0 and at study week 4
Breath Carbon Monoxide (CO)
Breath carbon monoxide readings collected using our app
Measured: Collected twice daily through the 4 week duration of the study
Salivary Cotinine
Salivary cotinine collected with rapid test, verified via smartphone app
Measured: Collected twice weekly during interim sampling period as well as a final test on the last day of week 4
Self-reported nicotine product use
The number of tobacco cigarettes, marijuana cigarettes, and other nicotine/tobacco products consumed. Will be collected with our app.
Measured: Collected daily from study week 1 to study week 4
Self-reported withdrawal symptom severity
On a scale from 0 to 9, participants will report their withdrawal symptom severity in our smartphone app. A higher score indicates more severe symptoms.
Measured: Collected daily from study week 1 to study week 4
Self-reported nicotine craving intensity
On a scale from 0 to 9, participants will report their nicotine craving intensity in our smartphone app. A higher score indicates more intense cravings.
Measured: Collected daily from study week 1 to study week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start16 Aug 2024
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
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
- Crossover
- Model description
- Mixed crossover-factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mikhail N Koffarnus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Mikhail N Koffarnus, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234722
- Sponsor's protocol ID
- 87440
- Other IDs
- 1U54DA058256-01
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace
- ClinicalTrials.gov ID
- NCT06234722
- Acronym / sponsor ID
- 87440
- Conditions
- Tobacco Use, Cigarette Use
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 473 participants (estimated)
- Lead sponsor
- Mikhail N KoffarnusUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Jan 2024 (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 look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 4-week experiment.
Detailed description
After granting informed consent, participants will complete a baseline assessment session. This will be followed by an extended 4-week sampling period to acclimate participants to their randomly assigned experimental cigarette and allow any shifts in product consumption patterns to materialize. In the final week of this sampling period, participants will complete behavioral assessments and a series of assessments to assess the impact of potential regulatory environments relevant to our aims.
Experimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in our 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 an online marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of 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. Tobacco and nicotine products will match the products found by surveying product availability vendors in the local communities. 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 we have shown to generate realistic results. They will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.
Baseline Assessment Session. The first experimental session will be an assessment session to collect information from participants on substance use patterns and addiction severity, as well as the results of behavioral and cognitive tasks that have measure components of our behavioral economic model of product valuation.
Sampling Period. After their assessment session, participants will be given a supply of their randomly assigned reduced-nicotine cigarette corresponding to two weeks of their typical cigarette consumption and asked to use the provided cigarettes as their only combusted tobacco product for 4 consecutive weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Mixed crossover-factorial
| Arm | Type | Receives |
|---|---|---|
| Rural - Conventional Cigarette | Placebo comparator | Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who reside in rural locales of Appalachian KY and receive conventional cigarettes during the sampling period. |
| Peri-Urban - Conventional Cigarette | Placebo comparator | Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who reside in peri-urban locales of Appalachian KY and receive conventional cigarettes during the sampling period. |
| Peri-Urban - Very Low Nicotine Cigarette | Active comparator | Drug: Very Low Nicotine Cigarette, Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who reside in peri-urban locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period. |
| Rural - Very Low Nicotine Cigarette | Active comparator | Drug: Very Low Nicotine Cigarette, Behavioral: Reduced nicotine regulatory environment, Behavioral: Restriction on characterizing flavors in combustible nicotine products, Behavioral: Restriction on characterizing flavors in noncombustible nicotine productsParticipants who reside in rural locales of Appalachian KY and receive very low nicotine cigarettes during the sampling period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 21 years old
- Consume nicotine and/or tobacco products daily
- Have no plans to quit nicotine/tobacco consumption or seek treatment in the subsequent 9 weeks
- 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 |
|---|---|---|
| Very Low Nicotine CigaretteParticipants will be assigned to one of two investigational cigarette nicotine levels for the duration of the experiment: 0.4mg/g or 15.8mg/g | Drug | Peri-Urban - Very Low Nicotine Cigarette, Rural - Very Low Nicotine Cigarette |
| Reduced nicotine regulatory environmentIn this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and only the participants' assigned investigational cigarette will be the only available combustible cigarette. | Behavioural | Peri-Urban - Conventional Cigarette, Peri-Urban - Very Low Nicotine Cigarette, Rural - Conventional Cigarette, Rural - Very Low Nicotine Cigarette |
| 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. Only tobacco or no flavored combustible nicotine products will be the only combustible nicotine products available. | Behavioural | Peri-Urban - Conventional Cigarette, Peri-Urban - Very Low Nicotine Cigarette, Rural - Conventional Cigarette, Rural - Very Low Nicotine Cigarette |
| 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. Only tobacco or no flavored noncombustible nicotine products will be the only noncombustible nicotine products available. | Behavioural | Peri-Urban - Conventional Cigarette, Peri-Urban - Very Low Nicotine Cigarette, Rural - Conventional Cigarette, Rural - Very Low Nicotine Cigarette |
Primary outcome
Aggregate behavioral economic demand across all participants under the proposed regulatory environments
Time frame: Assessed at study week 0 and at study week 4
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: Assessed at study week 0 and at study week 4
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.
11 secondary outcomes
Timeline Follow-Back (TLFB): Average of marijuana and nicotine use quantity
Time frame: Assessed at study week 0 and at study week 4
Fagerström Test for Nicotine Dependence (FTND)
Time frame: Assessed at study week 0 and at study week 4
Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: Assessed at study week 0 and at study week 4
Hypothetical quantity purchased in purchase tasks
Time frame: Assessed at study week 0 and at study week 4
Delay Discounting Tasks
Time frame: Assessed at study week 0 and at study week 4
Activity Level Questionnaire - Substance Use Version (ALQ-SUV)
Time frame: Assessed at study week 0 and at study week 4
Breath Carbon Monoxide (CO)
Time frame: Collected twice daily through the 4 week duration of the study
Salivary Cotinine
Time frame: Collected twice weekly during interim sampling period as well as a final test on the last day of week 4
Self-reported nicotine product use
Time frame: Collected daily from study week 1 to study week 4
Self-reported withdrawal symptom severity
Time frame: Collected daily from study week 1 to study week 4
Self-reported nicotine craving intensity
Time frame: Collected daily from study week 1 to study week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. Only deidentified data will be shared.
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
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 Very Low Nicotine Cigarette, Reduced nicotine regulatory environment and Restriction on characterizing flavors in combustible nicotine products in people with Tobacco Use and Cigarette Use, run by Mikhail N Koffarnus 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: enrolling by invitation, as of the sponsor's last update on 9 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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: Assessed at study week 0 and at study week 4). 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 9 Oct 2026.