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

Completed

• Conditions: Current Every Day Smoker; Cigarette Smoker
• Interventions: Device: Medical Device; Other: Questionnaire Administration; Behavioral: Tobacco Smoking

• Registration Number: NCT04060446
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (smoke cigarettes)	Medical Device	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.
Observational (smoke cigarettes)	Questionnaire Administration	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.
Observational (smoke cigarettes)	Tobacco Smoking	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Carbon monoxide (CO) boost	Up to 210 minutes	Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States