Cigarette SmokingNCT06001840

Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

A study testing Promotion factors and Mitigation strategies in people with Cigarette Smoking and Nicotine Vaping, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types. 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?: Promotion factors and Mitigation strategies
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2024to 31 Mar 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

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
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)

Who cannot join

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.

United States1 site

Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016

Other trials in United States

About this study

This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.

Read the detailed description

In the present study, we propose to examine some promotion factors and mitigation strategies and how they impact tobacco product legal and illegal purchases. Specifically, we have developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify the number, type, and characteristics of tobacco users who would seek illegal tobacco products and the conditions that would induce them to seek that option. The critical questions we seek to answer are whether changes in product standards and availability will engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive combustible product users, and dual cigarette/NVP users). Understanding the user types and the relevant conditions will inform greater tailoring of policy to diminish consumer interest in an illegal market.

Conditions: Cigarette Smoking, Nicotine Vaping
Being tested: Promotion factors, Mitigation strategies
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.

Promotion factorsBehavioural
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.
Mitigation strategiesBehavioural
Penalties: Penalties will be presented as a 60% chance of getting caught making illegal purchases. The consequences of illegal purchases include not receiving any study products from the ETM if they were caught and randomly drew that trial.

Study groups in NCT06001840
Study group	Role	What they receive
Experimental: 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: Promotion factors; Behavioral: Mitigation strategies
Experimental: 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: Promotion factors; Behavioral: Mitigation strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Budget Spent on Illegal Cigarettes Across Policy Conditions
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on illegal cigarettes across all trials was calculated for each policy scenario.
Measured: 1 day
Percent Budget Spent on Legal Cigarettes Across Policy Conditions
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on legal cigarettes across all trials was calculated for each policy scenario.
Measured: 1 day
Percent Budget Spent on E-cigarettes Across Policy Conditions
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on e-cigarettes across all trials was calculated for each policy scenario.
Measured: 1 day
Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on nicotine replacement theray across all trials was calculated for each policy scenario.
Measured: 1 day
Percent Budget Spent on Oral Nicotine/Tobacco Across Policy Conditions
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on oral nicotine/tobacco across all trials was calculated for each policy scenario.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202431 Mar 2025

First posted21 Aug 2023
Study start4 Jan 2024
Primary completion28 Feb 2025
Study completion31 Mar 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: We will examine two promotion policies. 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 very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06001840
Sponsor's protocol ID: 5P01CA200512
Status last verified: Jan 2026
First submitted: 14 Aug 2023
Last updated: 10 Feb 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases
ClinicalTrials.gov ID: NCT06001840
Acronym / sponsor ID: 5P01CA200512
Conditions: Cigarette Smoking, Nicotine Vaping
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
Collaborators: Medical University of South Carolina
Study start: 4 Jan 2024 (actual)
Primary completion: 28 Feb 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 21 Aug 2023 (actual)
Results: Posted 10 Feb 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 effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: We will examine two promotion policies. 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 very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.

Arm	Type	Receives
Experimental: Exclusive cigarette smokers	Experimental	Behavioral: Promotion factors, Behavioral: Mitigation strategiesExclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Experimental: Dual cigarette/ nicotine vaping product users	Experimental	Behavioral: Promotion factors, Behavioral: Mitigation strategiesDual 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 (8 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
Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).

Key exclusion criteria (5 listed)

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
Promotion factorsIn 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	Experimental: Dual cigarette/ nicotine vaping product users, Experimental: Exclusive cigarette smokers
Mitigation strategiesPenalties: Penalties will be presented as a 60% chance of getting caught making illegal purchases. The consequences of illegal purchases include not receiving any study products from the ETM if they were caught and randomly drew that trial.	Behavioural	Experimental: Dual cigarette/ nicotine vaping product users, Experimental: Exclusive cigarette smokers

Primary outcome

Percent Budget Spent on Illegal Cigarettes Across Policy Conditions
Time frame: 1 day
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on illegal cigarettes across all trials was calculated for each policy scenario.
Percent Budget Spent on Legal Cigarettes Across Policy Conditions
Time frame: 1 day
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on legal cigarettes across all trials was calculated for each policy scenario.
Percent Budget Spent on E-cigarettes Across Policy Conditions
Time frame: 1 day
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on e-cigarettes across all trials was calculated for each policy scenario.
Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions
Time frame: 1 day
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on nicotine replacement theray across all trials was calculated for each policy scenario.
Percent Budget Spent on Oral Nicotine/Tobacco Across Policy Conditions
Time frame: 1 day
The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on oral nicotine/tobacco across all trials was calculated for each policy scenario.

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Exclusive Cigarette Smokers	33	27
Experimental: Dual Cigarette/ Nicotine Vaping Product Users	32	26

Primary outcome: Percent Budget Spent on Illegal Cigarettes Across Policy Conditions

Time frame: 1 day. Mean (Standard Error). Unit: percentage of budget spent

Measure	Experimental: Exclusive Cigarette Smokers n = 27	Experimental: Dual Cigarette/ Nicotine Vaping Product Users n = 26
No Policy	40.78 (4.04)	38.41 (3.63)
Penalty only	12.14 (2.66)	9.64 (2.32)
VLNC only	71.20 (3.42)	65.18 (2.84)
Penalty + VLNC	26.31 (3.47)	20.94 (3.09)

Primary outcome: Percent Budget Spent on Legal Cigarettes Across Policy Conditions

Time frame: 1 day. Mean (Standard Error). Unit: percentage of budget spent

Measure	Experimental: Exclusive Cigarette Smokers n = 27	Experimental: Dual Cigarette/ Nicotine Vaping Product Users n = 26
No Policy	37.97 (3.73)	29.72 (3.28)
Penalty only	57.30 (3.59)	47.73 (3.30)
VLNC only	4.32 (1.31)	0.89 (0.37)
Penalty + VLNC	19.71 (2.84)	9.69 (2.06)

Primary outcome: Percent Budget Spent on E-cigarettes Across Policy Conditions

Time frame: 1 day. Mean (Standard Error). Unit: percentage of budget spent

Measure	Experimental: Exclusive Cigarette Smokers n = 27	Experimental: Dual Cigarette/ Nicotine Vaping Product Users n = 26
No Policy	10.01 (1.48)	23.06 (2.27)
Penalty only	20.16 (2.56)	27.15 (2.41)
VLNC only	11.49 (1.71)	24.06 (2.39)
Penalty + VLNC	37.63 (3.12)	46.51 (3.16)

Primary outcome: Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions

Time frame: 1 day. Mean (Standard Error). Unit: percentage of budget spent

Measure	Experimental: Exclusive Cigarette Smokers n = 27	Experimental: Dual Cigarette/ Nicotine Vaping Product Users n = 26
No Policy	2.00 (0.44)	3.67 (0.86)
Penalty only	3.11 (0.70)	4.56 (0.91)
VLNC only	3.46 (0.94)	4.38 (1.10)
Penalty + VLNC	8.71 (1.41)	6.89 (1.08)

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Exclusive Cigarette Smokers	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Experimental: Dual Cigarette/ Nicotine Vaping Product Users	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.

Roberta Freitas-Lemos, Ph.D. 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?

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 8 inclusion and 5 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 10 Feb 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 10 Feb 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?

Percent Budget Spent on Illegal Cigarettes Across Policy Conditions (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06001840.

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 10 Feb 2026.