Cigarette SmokingNCT07161050
Effects of a Low Nicotine Standard and Tobacco Prices on Illegal Cigarette Purchasing
A study testing Nicotine Content, Illegal cigarette price and E-cigarette price in people with Cigarette Smoking and E-cigarette Use, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
This study will investigate the effects of a very-low-nicotine cigarette (VLNC) standard, e-cigarette price, and illegal cigarette price on illegal product purchasing and alternative product use in a virtual marketplace. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking, E-cigarette Use
- What is being tested?
- Nicotine Content, Illegal cigarette price and E-cigarette price
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 7 Oct 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent Be at least 21 years of age or older Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm) Stable tobacco use patterns for at least two months
Who cannot join
- For exclusive cigarette smokers:
- Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).
- For dual cigarette/NVP users:
- Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use of closed nicotine salt system)
- For both groups:
- Have plans to move out of the area Have a serious or unstable physical or mental health condition Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study Being pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fralin Biomedical Research Institute at Virginia Tech Carilion
Roanoke, Virginia, 24016
Kirstin Gatchalian, 540-526-2071, kmgatch@vtc.vt.edu
Roberta Freitas-Lemos, PhD
About this study
This study will investigate the effects of a very-low-nicotine cigarette (VLNC) standard, e-cigarette price, and illegal cigarette price on illegal product purchasing and alternative product use in a virtual marketplace.
Read the detailed description
This experiment will examine the effects of a VLNC standard, electronic cigarette price, and illegal cigarette price on illegal cigarette purchasing. Exclusive cigarette smokers and dual cigarette/nicotine vaping product (NVP) users, stratified by age, will complete multiple scenarios in the legal Experimental Tobacco Marketplace. The investigators will examine the effects of a VLNC standard, predicted to promote illegal purchasing. In the NNC conditions, participants' preferred normal nicotine content (NNC) cigarettes, NVPs, and a variety of other products will be available in the ETM, and preferred NNC cigarettes will also be available in the illegal marketplace. In the VLNC standard conditions, a ban will permit only VLNCs legally in the ETM, but preferred NNC cigarettes will continue to be available illegal marketplace. In this experiment, which will be completed in the lab, we will test three levels of NVP prices and three levels of illegal cigarette prices in scenarios under a VLNC standard or NNC condition. This study will involve a total of three sessions, including an assessment session, an ETM session, and a follow-up phone call.
- Conditions
- Cigarette Smoking, E-cigarette Use
- Being tested
- Nicotine Content, Illegal cigarette price, E-cigarette price
- Keywords
- Experimental Tobacco Marketplace, Illegal cigarette
- 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.
Nicotine ContentBehavioural
Also called very-low nicotine standard
In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.
Illegal cigarette priceBehavioural
At each level of nicotine content, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). MP is market price.
E-cigarette priceBehavioural
At each level of nicotine content and illegal cigarette price, we will manipulate the price of e-cigarettes (1xMP, 1.5x MP, 2x MP). MP is the market price.
| 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: Behavioral: Nicotine Content; Behavioral: Illegal cigarette price; Behavioral: E-cigarette 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: Behavioral: Nicotine Content; Behavioral: Illegal cigarette price; Behavioral: E-cigarette price |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of budget allocated to each product category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace
The investigators will measure the percent of each partcipants' study budget spent on products from each category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace
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 posted8 Sep 2025
- Study start1 Dec 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 one ETM session with a total of 18 purchasing trials, 9 trials in each of the two conditions - NNC and VLNC. The participant's preferred cigarette will be available in both the LETM and iETM in the NNC condition. In the VLNC condition, the preferred cigarette will be available only in the iETM and VLN cigarettes will be available in the LETM. E-cigarettes, nicotine replacement therapy, snus, and nicotine pouches will be available throughout all trials in the LETM. Within each condition, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). At each level of illegal cigarette price, we will also manipulate the price of NVP (1/2x MP, 1x MP, 2x MP). This design will permit the investigation and comparison of the effects of a VLNC standard as well as changes in illegal and NVP price. The investigators will counterbalance the order of the conditions within the ETM session.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Freitas-Lemos, Virginia Polytechnic Institute and State University
- Investigators
- Roberta Freitas-Lemos, PhD, Principal investigator, Fralin Biomedical Research Institute at Virginia Tech Carilion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161050
- Sponsor's protocol ID
- VT IRB #25-813
- Other IDs
- 5P01CA200512
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Low Nicotine Standard and Tobacco Prices on Illegal Cigarette Purchasing
- ClinicalTrials.gov ID
- NCT07161050
- Acronym / sponsor ID
- VT IRB #25-813
- Conditions
- Cigarette Smoking, E-cigarette Use
- Keywords
- Experimental Tobacco Marketplace, Illegal cigarette
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Medical University of South Carolina
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 8 Sep 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.
This study will investigate the effects of a very-low-nicotine cigarette (VLNC) standard, e-cigarette price, and illegal cigarette price on illegal product purchasing and alternative product use in a virtual marketplace.
Detailed description
This experiment will examine the effects of a VLNC standard, electronic cigarette price, and illegal cigarette price on illegal cigarette purchasing. Exclusive cigarette smokers and dual cigarette/nicotine vaping product (NVP) users, stratified by age, will complete multiple scenarios in the legal Experimental Tobacco Marketplace. The investigators will examine the effects of a VLNC standard, predicted to promote illegal purchasing. In the NNC conditions, participants' preferred normal nicotine content (NNC) cigarettes, NVPs, and a variety of other products will be available in the ETM, and preferred NNC cigarettes will also be available in the illegal marketplace. In the VLNC standard conditions, a ban will permit only VLNCs legally in the ETM, but preferred NNC cigarettes will continue to be available illegal marketplace. In this experiment, which will be completed in the lab, we will test three levels of NVP prices and three levels of illegal cigarette prices in scenarios under a VLNC standard or NNC condition. This study will involve a total of three sessions, including an assessment session, an ETM session, and a follow-up phone call.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete one ETM session with a total of 18 purchasing trials, 9 trials in each of the two conditions - NNC and VLNC. The participant's preferred cigarette will be available in both the LETM and iETM in the NNC condition. In the VLNC condition, the preferred cigarette will be available only in the iETM and VLN cigarettes will be available in the LETM. E-cigarettes, nicotine replacement therapy, snus, and nicotine pouches will be available throughout all trials in the LETM. Within each condition, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). At each level of illegal cigarette price, we will also manipulate the price of NVP (1/2x MP, 1x MP, 2x MP). This design will permit the investigation and comparison of the effects of a VLNC standard as well as changes in illegal and NVP price. The investigators will counterbalance the order of the conditions within the ETM session.
| Arm | Type | Receives |
|---|---|---|
| Exclusive cigarette smokers | Experimental | Behavioral: Nicotine Content, Behavioral: Illegal cigarette price, Behavioral: E-cigarette priceExclusive 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 | Behavioral: Nicotine Content, Behavioral: Illegal cigarette price, Behavioral: E-cigarette priceDual 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 (1 listed)
- Provide informed consent Be at least 21 years of age or older Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm) Stable tobacco use patterns for at least two months
Key exclusion criteria (6 listed)
- Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).
- Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use of closed nicotine salt system)
- Have plans to move out of the area Have a serious or unstable physical or mental health condition Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study Being pregnant or lactating
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 ContentAlso: very-low nicotine standardIn the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM. | Behavioural | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
| Illegal cigarette priceAt each level of nicotine content, we will manipulate the price of illegal cigarettes (1xMP, 1.5x MP, 2x MP). MP is market price. | Behavioural | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
| E-cigarette priceAt each level of nicotine content and illegal cigarette price, we will manipulate the price of e-cigarettes (1xMP, 1.5x MP, 2x MP). MP is the market price. | Behavioural | Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers |
Primary outcome
Percent of budget allocated to each product category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace
Time frame: 1 day
The investigators will measure the percent of each partcipants' study budget spent on products from each category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace
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 16 Jan 2026.
- 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.
Roberta Freitas-Lemos, PhD principal investigator
Fralin Biomedical Research Institute at Virginia Tech Carilion
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 Content, Illegal cigarette price and E-cigarette price in people with Cigarette Smoking and E-cigarette Use, 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Jan 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?
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?
Contact Kirstin Gatchalian (540-526-2071, kmgatch@vtc.vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of budget allocated to each product category (eg, legal cigarettes, e-cigarettes, illegal cigarettes, etc) in the marketplace (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 16 Jan 2026.