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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04060446
Collaborator
National Cancer Institute (NCI) (NIH), University of Minnesota (Other)
8
Enrollment
1
Location
8.9
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Medical Device
  • Other: Questionnaire Administration
  • Behavioral: Tobacco Smoking

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation (COMET 2 2.1)
Actual Study Start Date :
Jun 6, 2019
Actual Primary Completion Date :
Mar 2, 2020
Actual Study Completion Date :
Mar 2, 2020

Arms and Interventions

Arm 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.

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

    • Other: Questionnaire Administration
    Ancillary studies

    Behavioral: Tobacco Smoking
    Smoke cigarettes
    Other Names:
  • Smoking

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Carbon monoxide (CO) boost [Up to 210 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Richard J O'Connor, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04060446
    Other Study ID Numbers:
    • I 68718
    • NCI-2019-04530
    • I 68718
    • P01CA217806
    • P30CA016056
    First Posted:
    Aug 19, 2019
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    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
    Additional relevant MeSH terms:
    Respiratory Aspiration

    Study Results

    No Results Posted as of Jul 15, 2022