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Can a phone study track how cigarette design changes smoking habits?

NCT ID NCT04514471

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

46 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

Lead sponsor

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

21 years and older

Sex

Anyone

Healthy volunteers

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

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

  • University of Minnesota

    Minneapolis, Minnesota, 55405, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.