Cigarette Smoking-Related CarcinomaCOMET 2 3 1NCT04744285

Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers

A study testing Cigarette packaging, Data capture and Questionnaire administration in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption. Read more about this study

Who is it for?: Ages 21 to 69 yearsHealthy volunteers can take part
Conditions the study is for: Cigarette Smoking-Related Carcinoma
What is being tested?: Cigarette packaging, Data capture and Questionnaire administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2020to 18 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 21-69 years old
Currently smoking daily, at least 5 cigarettes per day, for the past year:
Primarily using factory-made filtered cigarettes
Fair and above self-rated physical health (self-rated)
Fair and above self-rated mental health (self-rated)
Not planning to quit smoking in the next 30 days

Show all 14Show fewer

Able to converse, read, and write in English
Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component
Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins)
Alcohol Use Disorders Identification Test (AUDIT)-C <7 (i.e., no problematic alcohol consumption)
Cannibis use less than or equal to 5 days in the past month
No other illegal drug use in the past month (allow for prescription)
Not pregnant or breastfeeding or planning to become pregnant during the study period
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

Age < 21 or > 69
Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered
Planning to quit smoking in the next 30 days
Adults unable to consent
Minors (any persons under age 21)
Prisoners

Show all 14Show fewer

Poor physical health by self-report
Poor mental health by self-report:
Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress
AUDIT-C score >=7 (i.e. problematic alcohol consumption)
Cannabis use >5 days in past month
Other illegal drug use in past month
Pregnant or breastfeeding by self-report
No access to smartphone or videoconferencing

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)

Read the detailed description

PRIMARY OBJECTIVE:

To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking.

OUTLINE: Participants are randomized to 1 of 4 conditions.

CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

CONDITION II: Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

CONDITION III: Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

CONDITION IV: Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

Conditions: Cigarette Smoking-Related Carcinoma
Being tested: Cigarette packaging, Data capture, Questionnaire administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cigarette packagingOther
receive normal packet cigarette
Data captureOther
Attend video sessions
Questionnaire administrationOther
Ancillary studies

Study groups in NCT04744285
Study group	Role	What they receive
Condition 1 (normal cigarettes)	Active comparator	Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Receives: Other: Cigarette packaging; Other: Data capture; Other: Questionnaire administration
Condition II (cigarettes with neutral message)	Experimental	Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Receives: Other: Cigarette packaging; Other: Data capture; Other: Questionnaire administration
Condition III (cigarettes with compensation message)	Experimental	Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Receives: Other: Cigarette packaging; Other: Data capture; Other: Questionnaire administration
Condition IV cigarettes with blocking message	Experimental	Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Receives: Other: Cigarette packaging; Other: Data capture; Other: Questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Questionnaires of Product Evaluation
Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely).
Measured: At 2 weeks
Readiness to Quit
Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately.
Measured: At 2 weeks
Withdrawal
Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items.
Measured: At 2 weeks

Secondary outcomes (1)

Level of Exhaled Carbon Monoxide (CO)
level of CO measured in exhaled breath after a 15 seconds breathhold
Measured: At 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202018 Nov 2022

First posted8 Feb 2021
Study start4 Dec 2020
Primary completion18 Nov 2022
Study completion18 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cigarette Smoking-Related CarcinomaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04744285
Sponsor's protocol ID: I 757820
Other IDs: P01CA217806
Acronym: COMET 2 3 1
Status last verified: Dec 2023
First submitted: 28 Jan 2021
Last updated: 26 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)
ClinicalTrials.gov ID: NCT04744285
Acronym / sponsor ID: COMET 2 3 1 / I 757820
Conditions: Cigarette Smoking-Related Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 4 Dec 2020 (actual)
Primary completion: 18 Nov 2022 (actual)
Study completion: 18 Nov 2022 (actual)
First posted: 8 Feb 2021 (actual)
Results: Posted 26 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking.

OUTLINE: Participants are randomized to 1 of 4 conditions.

CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Condition 1 (normal cigarettes)	Active comparator	Other: Cigarette packaging, Other: Data capture, Other: Questionnaire administrationParticipants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
Condition II (cigarettes with neutral message)	Experimental	Other: Cigarette packaging, Other: Data capture, Other: Questionnaire administrationParticipants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
Condition III (cigarettes with compensation message)	Experimental	Other: Cigarette packaging, Other: Data capture, Other: Questionnaire administrationParticipants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
Condition IV cigarettes with blocking message	Experimental	Other: Cigarette packaging, Other: Data capture, Other: Questionnaire administrationParticipants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection

Who may qualify

Ages: 21 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Aged 21-69 years old
Currently smoking daily, at least 5 cigarettes per day, for the past year:
Fair and above self-rated physical health (self-rated)
Fair and above self-rated mental health (self-rated)
Not planning to quit smoking in the next 30 days

Key exclusion criteria (14 listed)

Age < 21 or > 69
Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered
Planning to quit smoking in the next 30 days
Adults unable to consent
Minors (any persons under age 21)

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
Cigarette packagingreceive normal packet cigarette	Other	Condition 1 (normal cigarettes), Condition II (cigarettes with neutral message), Condition III (cigarettes with compensation message), Condition IV cigarettes with blocking message
Data captureAttend video sessions	Other	Condition 1 (normal cigarettes), Condition II (cigarettes with neutral message), Condition III (cigarettes with compensation message), Condition IV cigarettes with blocking message
Questionnaire administrationAncillary studies	Other	Condition 1 (normal cigarettes), Condition II (cigarettes with neutral message), Condition III (cigarettes with compensation message), Condition IV cigarettes with blocking message

Primary outcome

Subjective Questionnaires of Product Evaluation
Time frame: At 2 weeks
Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely).
Readiness to Quit
Time frame: At 2 weeks
Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately.
Withdrawal
Time frame: At 2 weeks
Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items.

1 secondary outcome

Level of Exhaled Carbon Monoxide (CO)
Time frame: At 2 weeks

Results and safety

Results posted to the registry on 26 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Condition 1 (Normal Cigarettes)	31	30
Condition II (Cigarettes With Neutral Message)	29	28
Condition III (Cigarettes With Compensation Message)	33	31
Condition IV Cigarettes With Blocking Message	22	21

Primary outcome: Subjective Questionnaires of Product Evaluation

Time frame: At 2 weeks. Mean (Full Range). Unit: units on a scale

Measure	Condition 1 (Normal Cigarettes) n = 30	Condition II (Cigarettes With Neutral Message) n = 28	Condition III (Cigarettes With Compensation Message) n = 31	Condition IV Cigarettes With Blocking Message n = 21
How much did you like the puffs you just took?	4.27 (1 to 7)	3.86 (1 to 7)	4.16 (1 to 7)	4.9 (1 to 7)
How satisfying were the puffs you just took?	4.27 (1 to 7)	3.82 (1 to 7)	4.35 (1 to 7)	4.95 (1 to 7)
How high in nicotine do you think the puffs were?	4.33 (1 to 7)	4.11 (1 to 7)	4.65 (1 to 7)	4.43 (1 to 7)
How similar to your own brand were the puffs?	3.33 (1 to 7)	3.54 (1 to 7)	3.77 (1 to 7)	3.33 (1 to 7)
Strength of puffs on tongue	4.03 (1 to 7)	3.86 (1 to 7)	3.61 (1 to 7)	3.76 (1 to 7)
Strength of puffs in nose	3.4 (1 to 7)	3.21 (1 to 7)	3.03 (1 to 7)	2.95 (1 to 7)
Strength of puffs in back of mouth and throat	4.1 (1 to 7)	3.54 (1 to 7)	4.13 (1 to 7)	4.14 (1 to 7)
Strength of puffs in windpipe	4.13 (1 to 7)	3.61 (1 to 7)	4.0 (1 to 7)	4.19 (1 to 7)

Primary outcome: Readiness to Quit

Time frame: At 2 weeks. Mean (Full Range). Unit: score on a scale

Measure	Condition 1 (Normal Cigarettes) n = 30	Condition II (Cigarettes With Neutral Message) n = 28	Condition III (Cigarettes With Compensation Message) n = 31	Condition IV Cigarettes With Blocking Message n = 21
Value	6.27 (1 to 10)	5.79 (1 to 10)	6.58 (1 to 10)	6.24 (1 to 10)

Primary outcome: Withdrawal

Time frame: At 2 weeks. Mean (Full Range). Unit: score on a scale

Measure	Condition 1 (Normal Cigarettes) n = 30	Condition II (Cigarettes With Neutral Message) n = 28	Condition III (Cigarettes With Compensation Message) n = 31	Condition IV Cigarettes With Blocking Message n = 21
Value	13.2 (1 to 45)	12.3 (1 to 45)	8.8 (1 to 45)	13.9 (1 to 45)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 weeks after study enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Condition 1 (Normal Cigarettes)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Condition II (Cigarettes With Neutral Message)	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Condition III (Cigarettes With Compensation Message)	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Condition IV Cigarettes With Blocking Message	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cigarette Smoking-Related Carcinoma

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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 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?

A study testing Cigarette packaging, Data capture and Questionnaire administration in people with Cigarette Smoking-Related Carcinoma, 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 14 inclusion and 14 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 26 Dec 2023. 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?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subjective Questionnaires of Product Evaluation (time frame: At 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04744285.

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 26 Dec 2023.