Telehealth-Filter Ventilation ( COMET2P1 )
Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
3 other identifiers
interventional
164
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2021
CompletedFirst Submitted
Initial submission to the registry
July 6, 2021
CompletedFirst Posted
Study publicly available on registry
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedResults Posted
Study results publicly available
May 8, 2025
CompletedMay 8, 2025
May 1, 2025
2.7 years
July 6, 2021
April 4, 2025
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Ventilated Cigarette Filter
EXPERIMENTALFilters with approximately 24-32% filter ventilation
Unventilated Cigarette Filter
EXPERIMENTALFilters with approximately 0-5.0% filter ventilation
Interventions
Eligibility Criteria
You may qualify if:
- At least 21 years of age
- Biochemically confirmed regular cigarette smoker
- Daily smoker, 5-30 cigarettes per day.
- Usual brand cigarettes 16-36% ventilation
You may not qualify if:
- Unstable health
- Unstable medications
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, 55414, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Dorothy Hatsukami
- Organization
- Masonic Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy K Hatsukami, Ph.D
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2021
First Posted
July 21, 2021
Study Start
May 26, 2021
Primary Completion
February 15, 2024
Study Completion
March 21, 2024
Last Updated
May 8, 2025
Results First Posted
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will not be available until primary and secondary papers are accepted for publication
- 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.
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.