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

Cigarette Smoker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060446
• Other study ID #: I 68718
• Secondary ID: NCI-2019-04530I
• Status: Completed
• Start date: June 6, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoker
• Current Every Day Smoker
• Respiratory Aspiration

Intervention

Device:
• Medical Device
Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device

Other:
• Questionnaire Administration
Ancillary studies

Behavioral:
• Tobacco Smoking
Smoke cigarettes

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Carbon monoxide (CO) boost	Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO.	Up to 210 minutes