COMET2 Project 1 Filter Ventilation Study
Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
1 other identifier
interventional
118
1 country
2
Brief Summary
Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2018
Typical duration for phase_3
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
First Submitted
Initial submission to the registry
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedStudy Start
First participant enrolled
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2021
CompletedApril 29, 2022
April 1, 2022
3.1 years
July 12, 2018
April 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The total NNAL at Week 8 Visit
The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)
Week 8
Mean CPD based on 7 day IVR before week 8 visit.
The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.
Week 8
Secondary Outcomes (2)
Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline
Week 8
Number of cigarette-free days
Week 8
Study Arms (4)
Ventilated cigarettes only
EXPERIMENTALFilters with approximately 30-36% filter ventilation
Unventilated cigarettes only
EXPERIMENTALFilters with approximately 3.0-4.6% filter ventilation
Ventilated cigarettes + alternative nicotine delivery systems
EXPERIMENTALFilters with approximately 30-36% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch).
Unventilated cigarettes + ANDS
EXPERIMENTALFilters with approximately 3.0-4.6% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch).
Interventions
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Biochemically confirmed regular cigarette smoker
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
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy K Hatsukami, Ph.D
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2018
First Posted
August 20, 2018
Study Start
October 18, 2018
Primary Completion
December 9, 2021
Study Completion
December 9, 2021
Last Updated
April 29, 2022
Record last verified: 2022-04
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 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.