Tobacco UseNCT06442384
Remote Trial - Tobacco Product Standard (VLNC)
A study testing Tobacco and non-tobacco e-cigarettes and Tobacco only e-cigarettes in people with Tobacco Use, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. 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
- What is being tested?
- Tobacco and non-tobacco e-cigarettes and Tobacco only e-cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 7 Apr 2025
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-report of daily smoking of at least 5 to 25 cigarettes for >3 months by self-report.
- Carbon monoxide indicative of regular smoking (CO > 6ppm) prior to randomization.
- Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
- Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).
Who cannot join
- Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free <5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
- Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
- Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
- Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
- Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
- Recent experience with VLNC cigarettes (purchasing of the VLNC cigarettes in the past year)
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- Household member enrolled in the study concurrently.
- Participated in prior research study during the past three months that would impact baseline smoking or response to study products.
- Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.
- Unstable living environment that would compromise the ability to sequester study products or complete study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fully Remote Randomized Controlled Trial Exploring the Role of Non-combustible Tobacco Products in the Context of a Nicotine Product Standard for Cigarettes
The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.
- Conditions
- Tobacco Use
- Being tested
- Tobacco and non-tobacco e-cigarettes, Tobacco only e-cigarettes
- Keywords
- reducing nicotine cigarettes
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco and non-tobacco e-cigarettesOther
Participants with no e-cigarette restrictions.
Tobacco only e-cigarettesOther
Participants restricted to tobacco flavored e-cigarettes only.
| Study group | Role | What they receive |
|---|---|---|
| VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes | Experimental | Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention Receives: Other: Tobacco and non-tobacco e-cigarettes |
| VLNC cigarettes plus access to only tobacco flavored e-cigarettes | Experimental | Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention Receives: Other: Tobacco only e-cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants that drop-out by 4 week visit
Percent of participants that drop-out by 4 week visit
Measured: 4 weeks
Secondary outcomes (2)
Change in mean cigarettes per day (CPD)
Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 4 visits
Measured: Baseline to 4 weeks
Number of participants experiencing smoke free days
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start11 Sep 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: Study determined to be not feasible at this time due to limited availability of study product and limited availability of study products in the marketplace.
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.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442384
- Sponsor's protocol ID
- 2023LS188
- Status last verified
- Apr 2025
- First submitted
- 29 May 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Remote Randomized Controlled Trial Exploring the Role of Non-combustible Tobacco Products in the Context of a Nicotine Product Standard for Cigarettes
- ClinicalTrials.gov ID
- NCT06442384
- Acronym / sponsor ID
- 2023LS188
- Conditions
- Tobacco Use
- Keywords
- reducing nicotine cigarettes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study determined to be not feasible at this time due to limited availability of study product and limited availability of study products in the marketplace.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 4 Jun 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 pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes | Experimental | Other: Tobacco and non-tobacco e-cigarettesSmokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention |
| VLNC cigarettes plus access to only tobacco flavored e-cigarettes | Experimental | Other: Tobacco only e-cigarettesSmokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-report of daily smoking of at least 5 to 25 cigarettes for >3 months by self-report.
- Carbon monoxide indicative of regular smoking (CO > 6ppm) prior to randomization.
- Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
- Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).
Key exclusion criteria (10 listed)
- Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free <5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
- Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
- Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
- Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
- Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
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 |
|---|---|---|
| Tobacco and non-tobacco e-cigarettesParticipants with no e-cigarette restrictions. | Other | VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes |
| Tobacco only e-cigarettesParticipants restricted to tobacco flavored e-cigarettes only. | Other | VLNC cigarettes plus access to only tobacco flavored e-cigarettes |
Primary outcome
Percent of participants that drop-out by 4 week visit
Time frame: 4 weeks
Percent of participants that drop-out by 4 week visit
2 secondary outcomes
Change in mean cigarettes per day (CPD)
Time frame: Baseline to 4 weeks
Number of participants experiencing smoke free days
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Study determined to be not feasible at this time due to limited availability of study product and limited availability of study products in the marketplace.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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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.
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 Tobacco and non-tobacco e-cigarettes and Tobacco only e-cigarettes in people with Tobacco Use, run by Masonic Cancer Center, University of Minnesota 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 10 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: stopped early, as of the sponsor's last update on 10 Apr 2025. 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 was stopped early (reason given: Study determined to be not feasible at this time due to limited availability of study product and limited availability of study products in the marketplace.). Results are not available in the source record.
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 of participants that drop-out by 4 week visit (time frame: 4 weeks). 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 10 Apr 2025.