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

NCT ID: NCT04060446

Last Updated: 2022-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-06

Study Completion Date

2020-03-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoker Current Every Day Smoker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Medical Device

Intervention Type DEVICE

Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Tobacco Smoking

Intervention Type BEHAVIORAL

Smoke cigarettes

Interventions

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Medical Device

Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device

Intervention Type DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Tobacco Smoking

Smoke cigarettes

Intervention Type BEHAVIORAL

Other Intervention Names

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Device Medical Devices Smoking

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard J O'Connor

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2019-04530

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 68718

Identifier Type: OTHER

Identifier Source: secondary_id

P01CA217806

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 68718

Identifier Type: -

Identifier Source: org_study_id

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