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Completed

NCT Number: NCT04969783

Telehealth-Filter Ventilation ( COMET2P1 )

The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette.

The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.

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Key information

Conditions

Tobacco Use Behavior Cigarette Smoking Smoking Tobacco Smoking

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Tobacco Research Program, Minneapolis, Minnesota, United States

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About this study

This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples.

Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes.

Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed.

Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 21 years of age
  • Biochemically confirmed regular cigarette smoker
  • Daily smoker, 5-30 cigarettes per day.
  • Usual brand cigarettes 16-36% ventilation

Exclusion criteria

  • Unstable health
  • Unstable medications
  • Pregnant or nursing

Treatment and study plan

Ventilated Cigarette Filter

Other

Ventilated Cigarette Filter

Unventilated Cigarette Filter

Other

Unventilated Cigarette Filter

Primary outcomes

  1. Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]

    Time frame: 6 weeks randomized intervention

    Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

  2. Change in Cigarettes Per Day (CPD)

    Time frame: 7 days prior to week 0 visit and 7 days prior to week 6 visit

    Change in cigarettes per day, daily diary reviewed data.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
May 8, 2025

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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