Trial Outcomes & Findings for Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure (NCT NCT05157048)
NCT ID: NCT05157048
Last Updated: 2024-11-07
Results Overview
Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
COMPLETED
NA
42 participants
Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
2024-11-07
Participant Flow
We recruited individuals from the greater Philadelphia area from March 2022 through February 2023 using print and digital media advertisements and through contacting previous participants and individuals registered with an institutional clinical research database.
Of the 42 individuals who signed the consent form and enrolled in the study, 2 did not meet post-enrollment inclusion criteria, resulting in 40 participants being randomized to study conditions / completing the single session. To clarify our mixed design, all subjects sampled each filter type, but half of the sample received cigarettes in a black pack and half received cigarettes in light packs. Thus there are 2 groups, not 4, for which we present participant flow and sample characteristics.
Participant milestones
| Measure |
Light Pack Color
All participants smoked two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject factor), in counterbalanced order. Participants were randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor). Those in the light pack condition received cigarettes in Natural American Spirit Sky packs.
|
Dark Pack Color
All participants smoked two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject factor), in counterbalanced order. Participants were randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor). Those in the dark pack condition received cigarettes in Natural American Spirit Black packs.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
Baseline characteristics by cohort
| Measure |
Light Pack Color
n=21 Participants
All participants will be smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject conditions), in counterbalanced order. Participants will be randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor).
|
Dark Pack Color
n=19 Participants
All participants will be smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject conditions), in counterbalanced order. Participants will be randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor).
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White vs. Other Categories · White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White vs. Other Categories · Non-White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cigarettes per day
|
13.1 cigarettes per day
STANDARD_DEVIATION 4.4 • n=5 Participants
|
15.6 cigarettes per day
STANDARD_DEVIATION 7.7 • n=7 Participants
|
14.3 cigarettes per day
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Years smoking regularly
|
29.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
28.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Nicotine dependence
|
4.9 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
Charcoal filtered cigarette
|
15.8 puffs
Standard Error 1.8
|
16.7 puffs
Standard Error 1.9
|
|
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
Non-charcoal filtered cigarette
|
19.1 puffs
Standard Error 2.3
|
19.6 puffs
Standard Error 2.4
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)
Charcoal filtered cigarette
|
30.4 seconds
Standard Error 4.3
|
32.6 seconds
Standard Error 4.5
|
|
Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)
Non-charcoal filtered cigarette
|
41.4 seconds
Standard Error 6.1
|
41.2 seconds
Standard Error 6.4
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)
Charcoal filtered cigarette
|
257.7 seconds
Standard Error 28.9
|
290.4 seconds
Standard Error 30.3
|
|
Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)
Non-charcoal filtered cigarette
|
267.9 seconds
Standard Error 28.8
|
275.0 seconds
Standard Error 30.3
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Risk beliefs were captured using an 8-item scale that asked participants to compare each study cigarette to 'regular' cigarettes on eight statements (i.e., "lower in nicotine", "lower in tar", "less addictive", "less likely to cause cancer", "has fewer chemicals", "is healthier", "makes smoking safer", "helps people quit smoking") using a 5-point response scale (1='definitely untrue', 5='definitely true'). Responses were scored dichotomously ("untrue" responses scored as correct; "unsure"/"true" responses scored as incorrect) and summed to create an overall beliefs measure. Thus, responses are possible on a scale of 0-8, with a score of 0 indicating no correct beliefs and 8 indicating the participant was correct on all belief items.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Correct Beliefs About Reduced Risks
Charcoal filtered cigarette
|
3.8 score on a scale
Standard Error 0.6
|
3.8 score on a scale
Standard Error 0.6
|
|
Correct Beliefs About Reduced Risks
Non-charcoal filtered cigarette
|
2.9 score on a scale
Standard Error 0.6
|
3.2 score on a scale
Standard Error 0.6
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Perceived health risks were assessed using the mean of six items that asked participants to indicate on a 7-point Likert scale (1 = "very low risk", 7 = "very high risk") their risk of developing smoking-related health conditions (i.e., lung cancer, heart disease, stroke, emphysema, respiratory infections, and other cancers) from regular use of each study cigarette.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Perceived Health Risks Summary Score
Charcoal-filtered cigarette
|
5.6 score on a scale
Standard Error 0.3
|
5.4 score on a scale
Standard Error 0.3
|
|
Perceived Health Risks Summary Score
Non-charcoal filtered cigarette
|
5.3 score on a scale
Standard Error 0.3
|
5.3 score on a scale
Standard Error 0.3
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Subjective ratings were assessed with THE Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Product Harshness (Subjective Rating Subscale 1)
Charcoal filtered cigarette
|
42.1 score on a scale
Standard Error 4.4
|
42.6 score on a scale
Standard Error 4.6
|
|
Product Harshness (Subjective Rating Subscale 1)
Non-charcoal filtered cigarette
|
24.7 score on a scale
Standard Error 4.7
|
26.2 score on a scale
Standard Error 5.0
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Smoking Satisfaction (Subjective Rating Subscale 2)
Charcoal filtered cigarette
|
65.8 score on a scale
Standard Error 4.2
|
55.9 score on a scale
Standard Error 4.4
|
|
Smoking Satisfaction (Subjective Rating Subscale 2)
Non-charcoal filtered cigarette
|
43.0 score on a scale
Standard Error 4.9
|
36.2 score on a scale
Standard Error 5.2
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Positive Sensory Experience (Subjective Rating Subscale 3)
Charcoal filtered cigarette
|
59.3 score on a scale
Standard Error 5.2
|
47.5 score on a scale
Standard Error 5.4
|
|
Positive Sensory Experience (Subjective Rating Subscale 3)
Non-charcoal filtered cigarette
|
48.4 score on a scale
Standard Error 5.2
|
48.1 score on a scale
Standard Error 5.4
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Cleanliness (Subjective Rating Subscale 4)
Charcoal filtered cigarette
|
72.4 score on a scale
Standard Error 5.8
|
47.7 score on a scale
Standard Error 6.1
|
|
Cleanliness (Subjective Rating Subscale 4)
Non-charcoal filtered cigarette
|
70.5 score on a scale
Standard Error 5.5
|
49.3 score on a scale
Standard Error 5.8
|
PRIMARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)CO will be measured in parts per million (ppm) using the Vitalograph BreathCO carbon monoxide monitor (Lenexa, KS) at the onset of the laboratory visit, as well as before and after each cigarette smoked. CO boost - the change in CO values resulting from smoking a cigarette - crudely estimates smoke exposure due to smoking an individual cigarette.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Carbon Monoxide (CO) Boost
Charcoal-filtered cigarette
|
4.6 parts per million
Standard Error 0.7
|
3.6 parts per million
Standard Error 0.7
|
|
Carbon Monoxide (CO) Boost
Non-charcoal filtered cigarette
|
5.0 parts per million
Standard Error 0.7
|
2.4 parts per million
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)A hypothetical cigarette purchase task, asked how many study cigarettes participants would purchase in a typical day across a range of escalating prices from free up to $1.45 per cigarette, chosen to reflect double the current median price of Natural American Spirit brands in the U.S. However, because 35-40% of participants failed to reach breakpoint (i.e., the price point at which consumption drops to 0), we report observed values for demand index of intensity (number of cigarettes consumed for free) only.
Outcome measures
| Measure |
Light Pack Color
n=21 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
Dark Pack Color
n=19 Participants
All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark).
|
|---|---|---|
|
Intensity
Charcoal-filtered cigarette
|
15.2 cigarettes per day
Standard Error 2.5
|
19.7 cigarettes per day
Standard Error 2.7
|
|
Intensity
Non-charcoal filtered cigarette
|
12.7 cigarettes per day
Standard Error 2.5
|
18.8 cigarettes per day
Standard Error 2.7
|
Adverse Events
Light Pack Color
Dark Pack Color
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