SmokingNCT04514471
Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes
A study testing Minimally Ventilated non-menthol cigarettes and Ventilated non-menthol cigarettes in people with Smoking, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Minimally Ventilated non-menthol cigarettes and Ventilated non-menthol cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 30 Jun 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
- Male or females at least 21 years of age or older
- Smoking menthol cigarettes most of the time (80% of cigarette purchases).
- Self-report of daily smoking of at least 5 - 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 or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys.
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 30 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 at each site).
- Excessive drinking or problems with drinking or drugs (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 biomarkers or patient safety to be determined by the licensed medical professional).
- Vital signs outside of the following range:
Show all 17Show fewer
- Systolic BP greater than or equal to 160
- Diastolic BP greater than or equal to 100
- Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- Heart rate greater than or equal to 105 bpm
- Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- (Participants failing for heart rate or blood pressure will be allowed to re-screen once).
- 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.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55405
About this study
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g. nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.
- Conditions
- Smoking
- Being tested
- Minimally Ventilated non-menthol cigarettes, Ventilated non-menthol cigarettes
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Ventilated non-menthol cigarettesOther
4 week intervention where participants will be using minimally ventilated non-menthol cigarettes.
Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
Ventilated non-menthol cigarettesOther
4 week intervention where participants will be using ventilated non-menthol cigarettes.
Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Menthol Cigarette Smokers Group 1 | Experimental | Smokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes. Receives: Other: Ventilated non-menthol cigarettes |
| Menthol Cigarettes Smokers Group 2 | Active comparator | Smokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes. Receives: Other: Minimally Ventilated non-menthol cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Dropped Out
Percentage of Participants that dropped out by week 4.
Measured: Baseline through Week 4
Feasibility of Approach - Data Collection
Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and interview
Measured: Baseline through Week 4
Cigarettes Smoked Per Day
Change in mean Cigarettes Per Day (CPD) based on 7 day ITR data before visit. Randomized participants (low vs moderate FV), between-group difference in change in cigarettes per day from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cigarettes per day (CPD) was calculated as the mean number of cigarettes smoked per day based on daily self-reported cigarette use collected via interactive text response (ITR) surveys. Change scores were computed as the difference between the mean CPD at Week 4 and the mean CPD at baseline for each participant, and group differences reflect the between-arm difference in these change scores.
Measured: Baseline through Week 4
Secondary outcomes (3)
Cotinine Change
Change in cotinine from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in cotinine from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cotinine was measured from blood samples collected using volumetric absorptive micro sampling (VAMS) and analyzed using liquid chromatography-mass spectrometry. Due to skewness, cotinine values were log-transformed, and change was calculated as the log ratio of Week 4 to baseline levels. Group differences represent the between-arm difference in these log-transformed changes.
Measured: Baseline through week 4
Carbon Monoxide Changes
Change in Carbon Monoxide from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in carbon monoxide from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Exhaled carbon monoxide (ppm) was measured remotely using a portable CO monitor during scheduled study visits. Change scores were calculated as Week 4 minus baseline CO levels for each participant, and group differences represent the between-arm difference in these change scores.
Measured: Baseline through Week 4
Quit Attempts
Number of 24 hour quit attempts analyzed using regression estimate. Randomized participants (low vs moderate FV), between-group difference in quit attempt from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups.
Measured: Baseline through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start18 Mar 2024
- Primary completion5 Jun 2025
- Study completion30 Jun 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 SmokingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, between-subject, randomized multi-center pilot study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, PH.D, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514471
- Sponsor's protocol ID
- 2020LS110
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2020
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes
- ClinicalTrials.gov ID
- NCT04514471
- Acronym / sponsor ID
- 2020LS110
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g. nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, between-subject, randomized multi-center pilot study
| Arm | Type | Receives |
|---|---|---|
| Menthol Cigarette Smokers Group 1 | Experimental | Other: Ventilated non-menthol cigarettesSmokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes. |
| Menthol Cigarettes Smokers Group 2 | Active comparator | Other: Minimally Ventilated non-menthol cigarettesSmokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or females at least 21 years of age or older
- Smoking menthol cigarettes most of the time (80% of cigarette purchases).
- Self-report of daily smoking of at least 5 - 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 or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys.
Key exclusion criteria (17 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 30 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 at each site).
- Excessive drinking or problems with drinking or drugs (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 biomarkers or 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 |
|---|---|---|
| Minimally Ventilated non-menthol cigarettes4 week intervention where participants will be using minimally ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention. | Other | Menthol Cigarettes Smokers Group 2 |
| Ventilated non-menthol cigarettes4 week intervention where participants will be using ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention. | Other | Menthol Cigarette Smokers Group 1 |
Primary outcome
Percentage of Participants That Dropped Out
Time frame: Baseline through Week 4
Percentage of Participants that dropped out by week 4.
Feasibility of Approach - Data Collection
Time frame: Baseline through Week 4
Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and interview
Cigarettes Smoked Per Day
Time frame: Baseline through Week 4
Change in mean Cigarettes Per Day (CPD) based on 7 day ITR data before visit. Randomized participants (low vs moderate FV), between-group difference in change in cigarettes per day from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cigarettes per day (CPD) was calculated as the mean number of cigarettes smoked per day based on daily self-reported cigarette use collected via interactive text response (ITR) surveys. Change scores were computed as the difference between the mean CPD at Week 4 and the mean CPD at baseline for each participant, and group differences reflect the between-arm difference in these change scores.
3 secondary outcomes
Cotinine Change
Time frame: Baseline through week 4
Carbon Monoxide Changes
Time frame: Baseline through Week 4
Quit Attempts
Time frame: Baseline through Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Dorothy Hatsukami, PH.D principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Ventilated non-menthol cigarettes and Ventilated non-menthol cigarettes in people with Smoking, 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 5 inclusion and 17 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 9 Sep 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 9 Sep 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?
Percentage of Participants That Dropped Out (time frame: Baseline through Week 4). The study lists 3 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 Sep 2026.