COMET2 Project 1 Filter Ventilation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This randomized, open label, controlled multi-site study will simulate a real world tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products. 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.

Official Title
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Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Conditions
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Smoking, Tobacco Use

Intervention / Treatment
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* Other: Ventilated cigarettes only
* Other: Unventilated cigarettes only
* Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
* Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Biochemically confirmed regular cigarette smoker Exclusion Criteria: Unstable health Unstable medications Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilated cigarettes only<br>Filters with approximately 30-36% filter ventilation | Other: Ventilated cigarettes only<br>* Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.<br>|
| Experimental: Unventilated cigarettes only<br>Filters with approximately 3.0-4.6% filter ventilation | Other: Unventilated cigarettes only<br>* Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.<br>|
| Experimental: Ventilated cigarettes + alternative nicotine delivery systems<br>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). | Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems<br>* Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.<br>|
| Experimental: Unventilated cigarettes + ANDS<br>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). | Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS<br>* Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline | Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT) | Week 8 | 
| Number of cigarette-free days | number of cigarette-free days based on no cigarettes smoked in the previous day on IVR (dropouts with no IVR data are assumed to be smoking) | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette smoking, Filter Ventilation