Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers

Study Overview
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Brief Summary
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This trial examines the effects of filter ventilation on sensory response, smoking topography, and inhalation in current every day cigarette smokers. The physical design features of cigarettes directly impact their appeal by influencing cognitive and sensory perceptions. The introduction of a now common design feature, filter ventilation, has led to greater public harm than benefit because of the potential for greater toxicity while enhancing product appeal among smokers. Ventilated cigarettes dilute smoke, which promotes perceptions of ?smoothness? and therefore lower health risk, contributing to the overall appeal of these products. The purpose of this study is to assess whether removing ventilation from cigarette filters lowers cigarette product appeal among smokers.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the link between marketing proxies for filter ventilation (product descriptors, packaging) and risk beliefs. OUTLINE: Patients smoke 5 cigarettes separated by 30 minute washout periods. Between 48 hours and 1 week later, patients smoke another 5 cigarettes separated by 30 minute washout period with CReSSMicro topography measurement device and BioRadio device for recording inhalation patterns.

Official Title
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Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation (COMET 2 2.1)

Conditions
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Cigarette Smoker, Current Every Day Smoker

Intervention / Treatment
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* Device: Medical Device
* Other: Questionnaire Administration
* Behavioral: Tobacco Smoking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently smoking daily at least 5 cigarettes per day for at least one year Primarily using factory-made filtered cigarettes with filter ventilation Fair and above physical health Fair and above mental health Not actively trying to quit smoking or planning to quit in the next 30 days Able to converse, read, and write in English No alcohol or illegal drug use Not pregnant or breastfeeding Exclusion Criteria: Currently smoking daily less than 5 cigarettes per day for at least one year Using roll-your-own cigarettes or unventilated filter cigarettes Currently using any other tobacco product daily Actively trying to quit smoking or planning to quit in the next 30 days Not able to converse, read, and write in English Adults unable to consent Prisoners Poor physical health by self report Poor mental health by self report Alcohol and illegal drug use Pregnant or breastfeeding by self report

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (smoke cigarettes)<br>Patients smoke 5 cigarettes separated by 30 minute washout periods. Between 48 hours and 1 week later, patients smoke another 5 cigarettes separated by 30 minute washout period with CReSSMicro topography measurement device and BioRadio device for recording inhalation patterns. | Device: Medical Device<br>* Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device<br>* Other names: Medical Devices;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Tobacco Smoking<br>* Smoke cigarettes<br>* Other names: Smoking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Cigarette Evaluation Questionnaire | Scored using an established algorithm. This results in 3 subscales (psychological reward, relief, reward) and 2 single items (aversion, respiratory sensation). | Up to 210 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide (CO) boost | Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO. | Up to 210 minutes |