Clinical trial NCT04060446: Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
Official title: Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation (COMET 2 2.1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoker
Current Every Day Smoker
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Minnesota
First posted: 2019-08-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently smoking daily at least 5 cigarettes per day for at least one year

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Cigarette Evaluation Questionnaire
timeFrame: Up to 210 minutes
Secondary outcomes:
measure: Carbon monoxide (CO) boost
timeFrame: Up to 210 minutes
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Richard J O'Connor
role: PRINCIPAL_INVESTIGATOR
References: