Cigarette SmokerNCT04060446
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
An observational study of Cigarette Smoker and Current Every Day Smoker, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker
- What is being tested?
- Medical Device, Questionnaire Administration and Tobacco Smoking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients currently smoking daily at least 5 cigarettes per day for at least one year
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Prisoners
- Poor physical health by self report
- Poor mental health by self report
- Alcohol and illegal drug use
- Pregnant or breastfeeding by self report
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Cigarette Smoker, Current Every Day Smoker
- Being tested
- Medical Device, Questionnaire Administration, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical DeviceDevice
Also called Device, Medical Devices
Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device
Questionnaire AdministrationOther
Ancillary studies
Tobacco SmokingBehavioural
Also called Smoking
Smoke cigarettes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medical Device; Other: Questionnaire Administration; Behavioral: Tobacco Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 210 minutes
Secondary outcomes (1)
Carbon monoxide (CO) boost
Defined as the difference between pre-smoking exhaled CO and postsmoking exhaled CO.
Measured: Up to 210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start6 Jun 2019
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Richard J O'Connor, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060446
- Sponsor's protocol ID
- I 68718
- Other IDs
- NCI-2019-04530, I 68718, P01CA217806, P30CA016056
- Status last verified
- Jul 2022
- First submitted
- 15 Aug 2019
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation (COMET 2 2.1)
- ClinicalTrials.gov ID
- NCT04060446
- Acronym / sponsor ID
- I 68718
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (smoke cigarettes) | – | Device: Medical Device, Other: Questionnaire Administration, Behavioral: Tobacco SmokingPatients 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 may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients currently smoking daily at least 5 cigarettes per day for at least one year
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical DeviceAlso: Device, Medical DevicesSmoke cigarettes with CReSSMicro topography measurement device and BioRadio device | Device | Observational (smoke cigarettes) |
| Questionnaire AdministrationAncillary studies | Other | Observational (smoke cigarettes) |
| Tobacco SmokingAlso: SmokingSmoke cigarettes | Behavioural | Observational (smoke cigarettes) |
Primary outcome
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).
1 secondary outcome
Carbon monoxide (CO) boost
Time frame: Up to 210 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
Related trials for Cigarette Smoker
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial
Lung Carcinoma
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J O'Connor principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoker and Current Every Day Smoker, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Cigarette Evaluation Questionnaire (time frame: Up to 210 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.