NCT04969783

Telehealth-Filter Ventilation ( COMET2P1 )

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Ventilated Cigarette Filter	Ventilated Cigarette Filter
OTHER	Unventilated Cigarette Filter	Unventilated Cigarette Filter

Timeline

• Start date: 2021-05-26
• Primary completion: 2024-02-15
• Completion: 2024-03-21
• First posted: 2021-07-21
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

2 sites across 1 country: United States