Cigarette SmokingMUSC-R 3aNCT06456671
Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study
A study testing All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price and Heated tobacco products at 1/2 market price. in people with Cigarette Smoking and Nicotine Vaping, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking, Nicotine Vaping
- What is being tested?
- All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price and Heated tobacco products at 1/2 market price.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 7 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- From CA, US, or EN
- At least 21 years old
- Smoking daily
- Smoking mostly or about equal amounts of factory-made cigarettes
- Does not currently vape (for exclusive smokers only)
- Vapes Daily (for dual users only)
Who cannot join
- There will be no additional exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a
This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.
Read the detailed description
An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.
- Conditions
- Cigarette Smoking, Nicotine Vaping
- Being tested
- All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price, Heated tobacco products at 1/2 market price., Nicotine pouch products at 1/2 market price.
- Medical subject headings
- Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All nicotine/ tobacco products at market priceOther
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Nicotine vaping products at 1/2 market priceOther
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Heated tobacco products at 1/2 market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Nicotine pouch products at 1/2 market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive cigarette smokers | Experimental | Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section. Receives: Other: All nicotine/ tobacco products at market price; Other: Nicotine vaping products at 1/2 market price; Other: Heated tobacco products at 1/2 market price.; Other: Nicotine pouch products at 1/2 market price. |
| Dual cigarette/ nicotine vaping product users | Experimental | Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section. Receives: Other: All nicotine/ tobacco products at market price; Other: Nicotine vaping products at 1/2 market price; Other: Heated tobacco products at 1/2 market price.; Other: Nicotine pouch products at 1/2 market price. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Budget Spent - CIGARETTES
Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (nicotine vaping products, heated tobacco products, nicotine pouch products) prices was assessed.
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price
Proportion of the budget spent on cigarettes
Measured: 1 day
Secondary outcomes (5)
Alternative Product Consumption - E-CIGARETTES
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price Data are reported as the number of puffs purchased at each condition and cigarette trial price.
Measured: 1 day
Alternative Product Consumption - HTP
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price Data is reported as the quantity purchased of HTP sticks at each condition and cigarette trial price.
Measured: 1 day
Alternative Product Consumption - Nicotine Pouches
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price
Data are reported as the quantity of nicotine pouches purchased for each condition and cigarette trial price.
Measured: 1 day
Alternative Product Consumption - Nicotine Replacement Therapy
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price Data are reported as the quantity of NRT gums/lozenges purchased at each condition and cigarette trial price.
Measured: 1 day
Alternative Product Consumption - Oral Tobacco Products
Participants completed the ETM task under four within-subject conditions:
Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price
Within each condition, cigarette prices ascended across 5 trials:
Trial Cigarette Price Multiplier
- 0.5x market price
- 1.0x market price (reference)
- 2.0x market price
- 4.0x market price
- 8.0x market price
Data are reported as the quantity of SNUS/DIP (oral tobacco products) purchased for each condition and cigarette trial price.
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 posted13 Jun 2024
- Study start29 Jul 2024
- Primary completion7 Jan 2025
- Study completion7 Jan 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 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price and market price).
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, University of Waterloo, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Roberta Freitas-Lemos, Virginia Polytechnic Institute and State University
- Investigators
- Warren K Bickel, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456671
- Sponsor's protocol ID
- IRB #24-520
- Other IDs
- 5P01CA200512
- Acronym
- MUSC-R 3a
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2024
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a
- ClinicalTrials.gov ID
- NCT06456671
- Acronym / sponsor ID
- MUSC-R 3a / IRB #24-520
- Conditions
- Cigarette Smoking, Nicotine Vaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, University of Waterloo, National Cancer Institute (NCI)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Posted 22 Apr 2026
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 investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.
Detailed description
An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price and market price).
| Arm | Type | Receives |
|---|---|---|
| Exclusive cigarette smokers | Experimental | Other: All nicotine/ tobacco products at market price, Other: Nicotine vaping products at 1/2 market price, Other: Heated tobacco products at 1/2 market price., Other: Nicotine pouch products at 1/2 market price.Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section. |
| Dual cigarette/ nicotine vaping product users | Experimental | Other: All nicotine/ tobacco products at market price, Other: Nicotine vaping products at 1/2 market price, Other: Heated tobacco products at 1/2 market price., Other: Nicotine pouch products at 1/2 market price.Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- From CA, US, or EN
- At least 21 years old
- Smoking daily
- Smoking mostly or about equal amounts of factory-made cigarettes
- Does not currently vape (for exclusive smokers only)
Key exclusion criteria (1 listed)
- There will be no additional exclusion criteria for this study.
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 |
|---|---|---|
| All nicotine/ tobacco products at market priceNicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions. | Other | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
| Nicotine vaping products at 1/2 market priceAvailability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. | Other | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
| Heated tobacco products at 1/2 market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. | Other | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
| Nicotine pouch products at 1/2 market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions. | Other | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
Primary outcome
Proportion of Budget Spent - CIGARETTES
Time frame: 1 day
Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (nicotine vaping products, heated tobacco products, nicotine pouch products) prices was assessed. Participants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Proportion of the budget spent on cigarettes
5 secondary outcomes
Alternative Product Consumption - E-CIGARETTES
Time frame: 1 day
Alternative Product Consumption - HTP
Time frame: 1 day
Alternative Product Consumption - Nicotine Pouches
Time frame: 1 day
Alternative Product Consumption - Nicotine Replacement Therapy
Time frame: 1 day
Alternative Product Consumption - Oral Tobacco Products
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Warren K Bickel, 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 study testing All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price and Heated tobacco products at 1/2 market price. in people with Cigarette Smoking and Nicotine Vaping, 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 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 22 Apr 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 22 Apr 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?
Proportion of Budget Spent - CIGARETTES (time frame: 1 day). 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 22 Apr 2026.