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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

StatusCompleted
PhaseNot applicable
Started2024-03-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section, Participant Flow v12
Results posted: 2026-09-09
Enrollment target64→46
Study sites2→1
InterventionsUnventilated filter cigarettes (Other), Ventilated filter cigarettes (Other)→Minimally Ventilated non-menthol cigarettes (Other), Ventilated non-menthol cigarettes (Other)
Eligibility criteria+2,609 characters
Inclusion Criteria: Male or females at least 21 years of age or older RegularSmoking menthol cigarettes most of the time (80% of cigarette smokerpurchases). CurrentlySelf-report of daily smoking anof eligibleat brandleast 5 - 25 cigarettes for >3 months by self-report. GenerallyCarbon goodmonoxide health Accessindicative of regular smoking (CO > 6ppm) prior to randomization. Has regular access to a smartphone or tablet andfor ause with CO device and smartphone, tablet or computer with a functioning camera and internet access for telehealth visits and surveys. Also must have internet access. Ex [...] [...]
Secondary endpoints3 entries, revised
Cotinine Change Carbon inMonoxide TotalChanges Quit Nicotine Equivalents (TNE) Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) Change in mean cigarettes per day (CPD)Attempts
Primary endpoints3 entries, revised
FeasibilityCigarettes ofSmoked approachPer - Drop outsDay Feasibility of approachApproach - MissingData DataCollection FeasibilityPercentage of approachParticipants -That ParticipantDropped SatisfactionOut
Study description-777 characters
Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual brand smoking. Subjects will then be randomly assigned for a period of 6 weeks to one of two conditions: 1) ventilated cigarettes; or 2) unvent [...]
Collaborators-21 characters
Ohio State University
Study title+145 characters
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
2026-01-08
Study Identification, Study Status, Sponsor/Collaborators v11
Collaborators2 to 1 entries
National Cancer Institute (NCI)
2025-07-11
Active, Not Recruiting→Completed Study Status v10
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2026-07-31→confirmed 2025-06-30
2025-06-09
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-02-01→confirmed 2025-06-05
Enrollment targetestimated 60→confirmed 64
Study sitesdetails revised at 2 of 2 sites
2024-07-15
Study Identification, Study Status, Sponsor/Collaborators v8
Collaborators1 to 2 entries
National Cancer Institute (NCI)
Show 7 earlier versions
2024-07-02
Withdrawn→Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusWithdrawn→Recruiting
Reason stoppedReplaced by another trial→not stated
Primary completion date2022-02-01→2026-02-01
Completion date2022-07-31→2026-07-31
Start dateestimated 2021-10-01→confirmed 2024-03-18
Enrollment target0→60
Study sitesdetails revised at 2 of 2 sites
2021-08-03
Not Yet Recruiting→Withdrawn Study Status, Study Design, Contacts/Locations v6
Trial statusNot Yet Recruiting→Withdrawn
Reason stoppednot stated→Replaced by another trial
Enrollment targetestimated 60→confirmed 0
Study sitescontacts updated at 2 of 2 sites
2021-06-03
Study Status v5
Start date2021-02-01→2021-10-01
2021-01-20
Study Status v4
Primary completion date2021-12-31→2022-02-01
Start date2020-12-10→2021-02-01
2020-10-26
Study Status v3
Start date2020-10-10→2020-12-10
2020-09-28
Study Status v2
Start date2020-09-10→2020-10-10
2020-09-15
Study Status v1
Start date2020-08-24→2020-09-10
2020-08-12
Original filing
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.
Trial Details
NCT Number NCT04514471
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Smoking
Enrollment 46 participants
Start Date 2024-03-18
Primary Completion 2025-06-05 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-09