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

NCT04060446 | Completed

• 4 other identifiers: I 68718NCI-2019-04530P01CA217806P30CA016056
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoker; Current Every Day Smoker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Carbon monoxide (CO) boost

  Up to 210 minutes

Study Arms (1)

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.

Device: Medical Device; Other: Questionnaire Administration; Behavioral: Tobacco Smoking

Interventions

Medical Device DEVICE

Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device

Also known as: Device, Medical Devices

Observational (smoke cigarettes)

Questionnaire Administration OTHER

Ancillary studies

Observational (smoke cigarettes)

Tobacco Smoking BEHAVIORAL

Smoke cigarettes

Also known as: Smoking

Observational (smoke cigarettes)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• University of Minnesota: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Equipment and Supplies; Smoking Devices

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Richard J O'Connor

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: June 6, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

US (1)