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NCT04744285: COMET 2 3 1

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

Completed NA Results posted Last updated 26 December 2023
What this trial tests

NA trial testing Cigarette packaging in Cigarette Smoking-Related Carcinoma in 115 participants. Completed in 18 November 2022.

Timeline
4 December 2020
Primary endpoint
18 November 2022
18 November 2022

Quick facts

Lead sponsorRoswell Park Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment115
Start date4 December 2020
Primary completion18 November 2022
Estimated completion18 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Roswell Park Cancer Institute

Who can join

Adults 21 to 69, any sex, with Cigarette Smoking-Related Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Questionnaires of Product Evaluation Primary · 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).

How much did you like the puffs you just took?
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.271 – 7
Condition II (Cigarettes With Neutral Message)3.861 – 7
Condition III (Cigarettes With Compensation Message)4.161 – 7
Condition IV Cigarettes With Blocking Message4.91 – 7
How satisfying were the puffs you just took?
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.271 – 7
Condition II (Cigarettes With Neutral Message)3.821 – 7
Condition III (Cigarettes With Compensation Message)4.351 – 7
Condition IV Cigarettes With Blocking Message4.951 – 7
How high in nicotine do you think the puffs were?
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.331 – 7
Condition II (Cigarettes With Neutral Message)4.111 – 7
Condition III (Cigarettes With Compensation Message)4.651 – 7
Condition IV Cigarettes With Blocking Message4.431 – 7
How similar to your own brand were the puffs?
GroupValue95% CI
Condition 1 (Normal Cigarettes)3.331 – 7
Condition II (Cigarettes With Neutral Message)3.541 – 7
Condition III (Cigarettes With Compensation Message)3.771 – 7
Condition IV Cigarettes With Blocking Message3.331 – 7
Strength of puffs on tongue
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.031 – 7
Condition II (Cigarettes With Neutral Message)3.861 – 7
Condition III (Cigarettes With Compensation Message)3.611 – 7
Condition IV Cigarettes With Blocking Message3.761 – 7
Strength of puffs in nose
GroupValue95% CI
Condition 1 (Normal Cigarettes)3.41 – 7
Condition II (Cigarettes With Neutral Message)3.211 – 7
Condition III (Cigarettes With Compensation Message)3.031 – 7
Condition IV Cigarettes With Blocking Message2.951 – 7
Strength of puffs in back of mouth and throat
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.11 – 7
Condition II (Cigarettes With Neutral Message)3.541 – 7
Condition III (Cigarettes With Compensation Message)4.131 – 7
Condition IV Cigarettes With Blocking Message4.141 – 7
Strength of puffs in windpipe
GroupValue95% CI
Condition 1 (Normal Cigarettes)4.131 – 7
Condition II (Cigarettes With Neutral Message)3.611 – 7
Condition III (Cigarettes With Compensation Message)4.01 – 7
Condition IV Cigarettes With Blocking Message4.191 – 7
Readiness to Quit Primary · 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.

GroupValue95% CI
Condition 1 (Normal Cigarettes)6.271 – 10
Condition II (Cigarettes With Neutral Message)5.791 – 10
Condition III (Cigarettes With Compensation Message)6.581 – 10
Condition IV Cigarettes With Blocking Message6.241 – 10
Withdrawal Primary · 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.

GroupValue95% CI
Condition 1 (Normal Cigarettes)13.21 – 45
Condition II (Cigarettes With Neutral Message)12.31 – 45
Condition III (Cigarettes With Compensation Message)8.81 – 45
Condition IV Cigarettes With Blocking Message13.91 – 45
Level of Exhaled Carbon Monoxide (CO) Secondary · At 2 weeks

level of CO measured in exhaled breath after a 15 seconds breathhold

GroupValue95% CI
Condition 1 (Normal Cigarettes)21.3± 11.0
Condition II (Cigarettes With Neutral Message)15.0± 10.7
Condition III (Cigarettes With Compensation Message)22.6± 16.6
Condition IV Cigarettes With Blocking Message27.6± 33.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Cigarette Smoking-Related Carcinoma

Currently open trials in the same condition.

Other Roswell Park Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04744285.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing