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

July 13, 2022 updated by: Roswell Park Cancer Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 210 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Carbon monoxide (CO) boost
Time Frame: Up to 210 minutes
Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO.
Up to 210 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Roswell Park Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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