Feasibility Study - Filter Ventilation

Study Overview
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Brief Summary
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This open label, between-subject, randomized multi-center pilot study will assess the feasibility of conducting a study remotely with telehealth visits to assess the effect of cigarettes with minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of tobacco toxicant exposure. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per a day will be collected remotely. Biological samples will be collected at home and mailed to the study clinic.

Detailed Description
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Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual brand smoking. Subjects will then be randomly assigned for a period of 6 weeks to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes. Subjects in each condition will be unblinded to simulate real world conditions. Subjects are provided with a debit card (ClinCard) that has been loaded with the appropriate amount of money to cover self-purchased usual brand cigarette in baseline and the assigned study cigarettes during intervention. Weekly telehealth visits will be conducted during baseline and the 6 weeks on study cigarettes to collect study measures, followed by a one month follow-up.

Official Title
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Feasibility of Conducting a Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Unventilated filter cigarettes
* Other: Ventilated filter cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age or older Regular cigarette smoker Currently smoking an eligible brand Generally good health Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access. Exclusion Criteria: Unstable health Uncontrolled high blood pressure Pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, between-subject, randomized multi-center pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unventilated Filter Cigarette<br>Conventional cigarette with approximately 6-7% (non-menthol) and 5-6% filter ventilation (menthol). | Other: Unventilated filter cigarettes<br>* Currently marketed unventilated cigarettes<br>|
| Active Comparator: Ventilated Filter Cigarette<br>Conventional cigarette with approximately 22-26% (non-menthol) and 35-38% filter ventilation (menthol). | Other: Ventilated filter cigarettes<br>* Currently marketed ventilated cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of approach - Drop outs | Percent of drop-outs in baseline and post-randomization. | Baseline through Week 6 | 
| Feasibility of approach - Missing Data | Extent (percent) of missing data | Baseline through Week 6 | 
| Feasibility of approach - Participant Satisfaction | Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses) | Baseline through Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Nicotine Equivalents (TNE) | The sum of nicotine and its metabolite concentrations used for evaluating nicotine exposure. | effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference | 
| Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) | One of the tobacco specific nitrosamines, one of the most important groups of carcinogens in tobacco products, which are formed from nicotine during the curing and processing of tobacco. | effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference | 
| Change in mean cigarettes per day (CPD) | The change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 6 visit. | effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference |