Trial Outcomes & Findings for Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (NCT NCT04744285)
NCT ID: NCT04744285
Last Updated: 2023-12-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
At 2 weeks
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Condition 1 (Normal Cigarettes)
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
33
|
22
|
|
Overall Study
COMPLETED
|
30
|
28
|
31
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Condition 1 (Normal Cigarettes)
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Condition 1 (Normal Cigarettes)
n=30 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
n=28 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
n=31 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
n=21 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 18 years old
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=110 Participants
|
|
Age, Customized
>= 18 years old
|
30 Participants
n=30 Participants
|
28 Participants
n=28 Participants
|
31 Participants
n=31 Participants
|
21 Participants
n=21 Participants
|
110 Participants
n=110 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=30 Participants
|
22 Participants
n=28 Participants
|
19 Participants
n=31 Participants
|
19 Participants
n=21 Participants
|
83 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=30 Participants
|
6 Participants
n=28 Participants
|
12 Participants
n=31 Participants
|
2 Participants
n=21 Participants
|
27 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
28 participants
n=28 Participants
|
31 participants
n=31 Participants
|
21 participants
n=21 Participants
|
110 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: At 2 weeksWill 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).
Outcome measures
| Measure |
Condition 1 (Normal Cigarettes)
n=30 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
n=28 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
n=31 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
n=21 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Subjective Questionnaires of Product Evaluation
Strength of puffs in chest
|
4.07 units on a scale
Interval 1.0 to 7.0
|
3.32 units on a scale
Interval 1.0 to 7.0
|
3.84 units on a scale
Interval 1.0 to 7.0
|
4.10 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
How much did you like the puffs you just took?
|
4.27 units on a scale
Interval 1.0 to 7.0
|
3.86 units on a scale
Interval 1.0 to 7.0
|
4.16 units on a scale
Interval 1.0 to 7.0
|
4.9 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
How satisfying were the puffs you just took?
|
4.27 units on a scale
Interval 1.0 to 7.0
|
3.82 units on a scale
Interval 1.0 to 7.0
|
4.35 units on a scale
Interval 1.0 to 7.0
|
4.95 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
How high in nicotine do you think the puffs were?
|
4.33 units on a scale
Interval 1.0 to 7.0
|
4.11 units on a scale
Interval 1.0 to 7.0
|
4.65 units on a scale
Interval 1.0 to 7.0
|
4.43 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
How similar to your own brand were the puffs?
|
3.33 units on a scale
Interval 1.0 to 7.0
|
3.54 units on a scale
Interval 1.0 to 7.0
|
3.77 units on a scale
Interval 1.0 to 7.0
|
3.33 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
Strength of puffs on tongue
|
4.03 units on a scale
Interval 1.0 to 7.0
|
3.86 units on a scale
Interval 1.0 to 7.0
|
3.61 units on a scale
Interval 1.0 to 7.0
|
3.76 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
Strength of puffs in nose
|
3.4 units on a scale
Interval 1.0 to 7.0
|
3.21 units on a scale
Interval 1.0 to 7.0
|
3.03 units on a scale
Interval 1.0 to 7.0
|
2.95 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
Strength of puffs in back of mouth and throat
|
4.1 units on a scale
Interval 1.0 to 7.0
|
3.54 units on a scale
Interval 1.0 to 7.0
|
4.13 units on a scale
Interval 1.0 to 7.0
|
4.14 units on a scale
Interval 1.0 to 7.0
|
|
Subjective Questionnaires of Product Evaluation
Strength of puffs in windpipe
|
4.13 units on a scale
Interval 1.0 to 7.0
|
3.61 units on a scale
Interval 1.0 to 7.0
|
4.0 units on a scale
Interval 1.0 to 7.0
|
4.19 units on a scale
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: At 2 weeksWill 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.
Outcome measures
| Measure |
Condition 1 (Normal Cigarettes)
n=30 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
n=28 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
n=31 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
n=21 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Readiness to Quit
|
6.27 score on a scale
Interval 1.0 to 10.0
|
5.79 score on a scale
Interval 1.0 to 10.0
|
6.58 score on a scale
Interval 1.0 to 10.0
|
6.24 score on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: At 2 weeksWill 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.
Outcome measures
| Measure |
Condition 1 (Normal Cigarettes)
n=30 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
n=28 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
n=31 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
n=21 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Withdrawal
|
13.2 score on a scale
Interval 1.0 to 45.0
|
12.3 score on a scale
Interval 1.0 to 45.0
|
8.8 score on a scale
Interval 1.0 to 45.0
|
13.9 score on a scale
Interval 1.0 to 45.0
|
SECONDARY outcome
Timeframe: At 2 weeksPopulation: This outcome data was only measured on a random subset of participants.
level of CO measured in exhaled breath after a 15 seconds breathhold
Outcome measures
| Measure |
Condition 1 (Normal Cigarettes)
n=6 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition II (Cigarettes With Neutral Message)
n=8 Participants
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.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition III (Cigarettes With Compensation Message)
n=8 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
Condition IV Cigarettes With Blocking Message
n=8 Participants
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
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies
|
|---|---|---|---|---|
|
Level of Exhaled Carbon Monoxide (CO)
|
21.3 parts per million
Standard Deviation 11.0
|
15.0 parts per million
Standard Deviation 10.7
|
22.6 parts per million
Standard Deviation 16.6
|
27.6 parts per million
Standard Deviation 33.6
|
Adverse Events
Condition 1 (Normal Cigarettes)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition II (Cigarettes With Neutral Message)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition III (Cigarettes With Compensation Message)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition IV Cigarettes With Blocking Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place