N/A N=164 Randomized Single-blind Basic Science

Telehealth-Filter Ventilation ( COMET2P1 )

Tobacco Use

Bottom Line

View on ClinicalTrials.gov: NCT04969783 ↗

Enrolled (actual)

164

Serious AEs

0.6%

Results posted

May 2025

Primary outcome: Primary: Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] — 0.97; 1.05 ng/g creatinine

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ventilated Cigarette Filter (Other); Unventilated Cigarette Filter (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Masonic Cancer Center, University of Minnesota
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]	0.97; 1.05	—
PRIMARY Change in Cigarettes Per Day (CPD)	-0.39; -0.17	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04969783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.