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 EvaluationPrimary· 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?
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.27
1 – 7
Condition II (Cigarettes With Neutral Message)
3.86
1 – 7
Condition III (Cigarettes With Compensation Message)
4.16
1 – 7
Condition IV Cigarettes With Blocking Message
4.9
1 – 7
How satisfying were the puffs you just took?
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.27
1 – 7
Condition II (Cigarettes With Neutral Message)
3.82
1 – 7
Condition III (Cigarettes With Compensation Message)
4.35
1 – 7
Condition IV Cigarettes With Blocking Message
4.95
1 – 7
How high in nicotine do you think the puffs were?
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.33
1 – 7
Condition II (Cigarettes With Neutral Message)
4.11
1 – 7
Condition III (Cigarettes With Compensation Message)
4.65
1 – 7
Condition IV Cigarettes With Blocking Message
4.43
1 – 7
How similar to your own brand were the puffs?
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
3.33
1 – 7
Condition II (Cigarettes With Neutral Message)
3.54
1 – 7
Condition III (Cigarettes With Compensation Message)
3.77
1 – 7
Condition IV Cigarettes With Blocking Message
3.33
1 – 7
Strength of puffs on tongue
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.03
1 – 7
Condition II (Cigarettes With Neutral Message)
3.86
1 – 7
Condition III (Cigarettes With Compensation Message)
3.61
1 – 7
Condition IV Cigarettes With Blocking Message
3.76
1 – 7
Strength of puffs in nose
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
3.4
1 – 7
Condition II (Cigarettes With Neutral Message)
3.21
1 – 7
Condition III (Cigarettes With Compensation Message)
3.03
1 – 7
Condition IV Cigarettes With Blocking Message
2.95
1 – 7
Strength of puffs in back of mouth and throat
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.1
1 – 7
Condition II (Cigarettes With Neutral Message)
3.54
1 – 7
Condition III (Cigarettes With Compensation Message)
4.13
1 – 7
Condition IV Cigarettes With Blocking Message
4.14
1 – 7
Strength of puffs in windpipe
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
4.13
1 – 7
Condition II (Cigarettes With Neutral Message)
3.61
1 – 7
Condition III (Cigarettes With Compensation Message)
4.0
1 – 7
Condition IV Cigarettes With Blocking Message
4.19
1 – 7
Readiness to QuitPrimary· 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.
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
6.27
1 – 10
Condition II (Cigarettes With Neutral Message)
5.79
1 – 10
Condition III (Cigarettes With Compensation Message)
6.58
1 – 10
Condition IV Cigarettes With Blocking Message
6.24
1 – 10
WithdrawalPrimary· 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.
Group
Value
95% CI
Condition 1 (Normal Cigarettes)
13.2
1 – 45
Condition II (Cigarettes With Neutral Message)
12.3
1 – 45
Condition III (Cigarettes With Compensation Message)
8.8
1 – 45
Condition IV Cigarettes With Blocking Message
13.9
1 – 45
Level of Exhaled Carbon Monoxide (CO)Secondary· At 2 weeks
level of CO measured in exhaled breath after a 15 seconds breathhold
Group
Value
95% 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 Message
27.6
± 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.
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Sponsor: as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
Last refreshed: 26 December 2023
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.