Telehealth-Filter Ventilation ( COMET2P1 )

Study Overview
=================
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.

Detailed Description
-----------------
This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples. Subjects (N=184; N=92 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial with one week of baseline; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed. Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers) will be collected remotely and dropped off at the clinic.

Official Title
-----------------
Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Conditions
-----------------
Tobacco Use

Intervention / Treatment
-----------------
* Other: Ventilated Cigarette Filter
* Other: Unventilated Cigarette Filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years of age Biochemically confirmed regular cigarette smoker Exclusion Criteria: Unstable health Unstable medications Pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilated Cigarette Filter<br>Filters with approximately 24-32% filter ventilation | Other: Ventilated Cigarette Filter<br>* Ventilated Cigarette Filter<br>|
| Experimental: Unventilated Cigarette Filter<br>Filters with approximately 0-5.0% filter ventilation | Other: Unventilated Cigarette Filter<br>* Unventilated Cigarette Filter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total NNAL: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol | Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit | 6 weeks | 
| Change in cigarettes per day (CPD) | The absolute change from baseline for the mean CPD based on the mean CPD for 7 days prior to baseline visit 1 and 7 days prior to week 6 visit using ITR (Interactive Text Response), daily diary reviewed data. | 7 days prior to baseline visit and 7 days prior to week 6 visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cigarette smoking, filter ventilation