Telehealth-Filter Ventilation ( COMET2P1 )

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Ventilated Cigarette Filter; Other: Unventilated Cigarette Filter

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota Tobacco Research Program
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventilated Cigarette Filter; Filters with approximately 24-32% filter ventilation	Other: Ventilated Cigarette Filter; Ventilated Cigarette Filter
Experimental: Unventilated Cigarette Filter; Filters with approximately 0-5.0% filter ventilation	Other: Unventilated Cigarette Filter; Unventilated Cigarette Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 weeks randomized intervention
Change in Cigarettes Per Day (CPD)	Change in cigarettes per day, daily diary reviewed data.	7 days prior to week 0 visit and 7 days prior to week 6 visit

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Dorothy K Hatsukami, Ph.D, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: cigarette smoking; filter ventilation
• Other Study ID Numbers: 2021LS034; P01CA217806 (U.S. NIH Grant/Contract); P01CA217806-S2 (Other Grant/Funding Number: NCI Trial ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
• IPD Sharing Time Frame: Data will not be available until primary and secondary papers are accepted for publication
• IPD Sharing Access Criteria: Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No