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Telehealth-Filter Ventilation ( COMET2P1 )

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04969783
Enrollment
164
Registered
2021-07-21
Start date
2021-05-26
Completion date
2024-03-21
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

cigarette smoking, filter ventilation

Brief summary

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.

Detailed description

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.

Interventions

OTHERVentilated Cigarette Filter

Ventilated Cigarette Filter

OTHERUnventilated Cigarette Filter

Unventilated Cigarette Filter

Sponsors

Ohio State University
CollaboratorOTHER
Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Single blind

Intervention model description

Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]6 weeks randomized interventionAbsolute 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).
Change in Cigarettes Per Day (CPD)7 days prior to week 0 visit and 7 days prior to week 6 visitChange in cigarettes per day, daily diary reviewed data.

Countries

United States

Participant flow

Participants by arm

ArmCount
Ventilated Cigarette Filter
Filters with approximately 24-32% filter ventilation Ventilated Cigarette Filter: Ventilated Cigarette Filter
80
Unventilated Cigarette Filter
Filters with approximately 0-5.0% filter ventilation Unventilated Cigarette Filter: Unventilated Cigarette Filter
84
Total164

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up20
Overall StudyPhysician Decision60
Overall StudyWithdrawal by Subject40

Baseline characteristics

CharacteristicTotalVentilated Cigarette FilterUnventilated Cigarette Filter
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants2 Participants1 Participants
Age, Categorical
Between 18 and 65 years
161 Participants78 Participants83 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants4 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
156 Participants76 Participants80 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
13 Participants5 Participants8 Participants
Race (NIH/OMB)
More than one race
6 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
142 Participants69 Participants73 Participants
Region of Enrollment
United States
164 participants80 participants84 participants
Sex: Female, Male
Female
100 Participants52 Participants48 Participants
Sex: Female, Male
Male
64 Participants28 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 84
other
Total, other adverse events
73 / 8074 / 84
serious
Total, serious adverse events
1 / 800 / 84

Outcome results

Primary

Change in Cigarettes Per Day (CPD)

Change in cigarettes per day, daily diary reviewed data.

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

ArmMeasureValue (MEAN)Dispersion
Ventilated Cigarette FilterChange in Cigarettes Per Day (CPD)-0.39 Cigarettes per dayStandard Deviation 2.73
Unventilated Cigarette FilterChange in Cigarettes Per Day (CPD)-0.17 Cigarettes per dayStandard Deviation 3.41
Primary

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

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).

Time frame: 6 weeks randomized intervention

ArmMeasureValue (MEDIAN)
Ventilated Cigarette FilterChange in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]0.97 ng/g creatinine
Unventilated Cigarette FilterChange in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]1.05 ng/g creatinine

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026