Can a phone study track how cigarette design changes smoking habits?
NCT ID NCT04514471
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This study tested whether a remote, telehealth approach can work to study how cigarette filter ventilation (the tiny holes in the filter) affects smoking behavior and exposure to harmful chemicals. 64 adult smokers participated from home, using their own devices for video visits and mailing in samples. The goal was to see if this method is practical, not to test a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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46 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55405, United States
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Other studies related to the condition(s) this trial covers.
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