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Completed

NCT Number: NCT04060446

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

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.

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Key information

Conditions

Cigarette Smoker Current Every Day Smoker

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device

Device

Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device

Other names: Device, Medical Devices

Questionnaire Administration

Other

Ancillary studies

Tobacco Smoking

Behavioral

Smoke cigarettes

Other names: Smoking

Primary outcomes

  1. Modified Cigarette Evaluation Questionnaire

    Time frame: 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 outcomes

  1. Carbon monoxide (CO) boost

    Time frame: Up to 210 minutes

    Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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