Telehealth-Filter Ventilation ( COMET2P1 )

Not Applicable

Completed

• Conditions: Tobacco Use
• Interventions: Other: Unventilated Cigarette Filter; Other: Ventilated Cigarette Filter

• Registration Number: NCT04969783
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study Start: 2021-05-26
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Primary Completion: 2024-02-15
• Study Completion: 2024-03-21
• Results First Submitted: 2025-04-04
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unventilated Cigarette Filter	Unventilated Cigarette Filter	Filters with approximately 0-5.0% filter ventilation
Ventilated Cigarette Filter	Ventilated Cigarette Filter	Filters with approximately 24-32% filter ventilation

Primary Outcome Measures

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

Trial Locations

Locations (2)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

University of Minnesota Tobacco Research Program; 🇺🇸 Minneapolis, Minnesota, United States