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

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

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.

Study Overview

• Status: Completed
• Conditions: Current Every Day Smoker; Cigarette Smoker
• Intervention / Treatment: Other: Questionnaire Administration; Device: Medical Device; Behavioral: Tobacco Smoking

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients currently smoking daily at least 5 cigarettes per day for at least one year

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (smoke cigarettes); 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.	Other: Questionnaire Administration; Ancillary studies; Device: Medical Device; Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device; Other Names: Device; Medical Devices; Behavioral: Tobacco Smoking; Smoke cigarettes; Other Names: Smoking

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2019
• Primary Completion (ACTUAL): March 2, 2020
• Study Completion (ACTUAL): March 2, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: I 68718 (OTHER: Roswell Park Cancer Institute); P30CA016056 (U.S. NIH Grant/Contract); NCI-2019-04530 (REGISTRY: CTRP (Clinical Trial Reporting Program)); P01CA217806 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No