Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2018-10-18
2021-12-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM
NCT03306173
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
NCT04060446
Cigarette and E-cigarette Flavors Manipulations in the Experimental Tobacco Marketplace
NCT05110872
Cessation Screening Project
NCT04188873
Innovative Interventions for Smoking Cessation
NCT01050569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS.
Smokers will undergo an in person screening and then a 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money.
Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ventilated cigarettes only
Filters with approximately 30-36% filter ventilation
Ventilated cigarettes only
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
Unventilated cigarettes only
Filters with approximately 3.0-4.6% filter ventilation
Unventilated cigarettes only
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
Ventilated cigarettes + alternative nicotine delivery systems
Filters with approximately 30-36% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch).
Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
Unventilated cigarettes + ANDS
Filters 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).
Access to Experimental Marketplace: Unventilated cigarettes + ANDS
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ventilated cigarettes only
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
Unventilated cigarettes only
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
Access to Experimental Marketplace: Unventilated cigarettes + ANDS
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Biochemically confirmed regular cigarette smoker
Exclusion Criteria
* Unstable medications
* Pregnant or nursing
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio State University
OTHER
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dorothy K Hatsukami, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018NTLS083
Identifier Type: -
Identifier Source: org_study_id
NCT03715491
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.