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Completed

NCT Number: NCT04514471

Feasibility Study - Filter Ventilation

This open label, between-subject, randomized multi-center pilot study will assess the feasibility of conducting a study remotely with telehealth visits to assess the effect of cigarettes with minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of tobacco toxicant exposure. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per a day will be collected remotely. Biological samples will be collected at home and mailed to the study clinic.

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Key information

Conditions

Tobacco Use Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

About this study

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) unventilated cigarettes. Subjects in each condition will be unblinded to simulate real world conditions. Subjects are provided with a debit card (ClinCard) that has been loaded with the appropriate amount of money to cover self-purchased usual brand cigarette in baseline and the assigned study cigarettes during intervention. Weekly telehealth visits will be conducted during baseline and the 6 weeks on study cigarettes to collect study measures, followed by a one month follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 years of age or older
  • Regular cigarette smoker
  • Currently smoking an eligible brand
  • Generally good health
  • Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access.

Exclusion criteria

  • Unstable health
  • Uncontrolled high blood pressure
  • Pregnant or breast-feeding

Treatment and study plan

Unventilated filter cigarettes

Other

Currently marketed unventilated cigarettes

Ventilated filter cigarettes

Other

Currently marketed ventilated cigarettes

Primary outcomes

  1. Feasibility of approach - Drop outs

    Time frame: Baseline through Week 6

    Percent of drop-outs in baseline and post-randomization.

  2. Feasibility of approach - Missing Data

    Time frame: Baseline through Week 6

    Extent (percent) of missing data

  3. Feasibility of approach - Participant Satisfaction

    Time frame: Baseline through Week 6

    Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses)

Secondary outcomes

  1. Change in Total Nicotine Equivalents (TNE)

    Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

    The sum of nicotine and its metabolite concentrations used for evaluating nicotine exposure.

  2. Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

    Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

    One of the tobacco specific nitrosamines, one of the most important groups of carcinogens in tobacco products, which are formed from nicotine during the curing and processing of tobacco.

  3. Change in mean cigarettes per day (CPD)

    Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

    The change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 6 visit.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • Ohio State University

Registry information

Official study title

Feasibility of Conducting a Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2020
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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