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Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure

Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05157048
Acronym
SKY Pilot
Enrollment
42
Registered
2021-12-14
Start date
2022-03-10
Completion date
2023-02-14
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Behaviors

Brief summary

This single laboratory session pilot study will examine the acute effects of cigarette filter type and packaging on initial product perceptions, use, and exposure. Forty adult daily smokers will be randomized to smoke two study-supplied commercially-available cigarettes interspersed by 45 minutes, completing pre- and post-cigarette carbon monoxide and questionnaire measures. We will use a 2 x 2 mixed factorial design to manipulate cigarette filter type (within-subject: charcoal vs. non-charcoal) and packaging (between-subject: light vs. dark).

Detailed description

We will recruit 40 adult daily, non-menthol smokers to a single 2-hr laboratory study where they will smoke two study-provided \[commercially available\] cigarettes, each for a 10-min ad lib period, and then complete product perception and use measures. Smoking sessions will be video recorded and scored to capture puffing behavior, and carbon monoxide (CO) assessments will be collected before and after smoking to assess changes in acute smoke exposure. We will use a 2 x 2 mixed factorial design to manipulate the study-provided cigarette's packaging (between subject factor: light colored 'Sky' package vs. black NAS package; both industry-made) and filter type (within-subject factor: charcoal filter vs. non-charcoal filter; cigarettes will appear identical despite differences in filter composition). Primary outcomes will be product perceptions (risk perceptions, subjective ratings), use behaviors (puffing behavior and purchase task), and acute toxicant exposure (changes in CO).

Interventions

OTHERCharcoal-filtered cigarette

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

OTHERNon-charcoal filtered cigarette

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will be blinded to both the marketing and cigarette condition manipulations

Intervention model description

Single-session study utilizing a 2 x 2 mixed factorial design

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months. * Smokers of primarily non-menthol cigarettes. * Not currently undergoing smoking cessation treatment or trying to quit. * Able to communicate fluently in English (speaking, writing, and reading). * Capable of giving written informed consent.

Exclusion criteria

Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study: Smoking Behavior 1. Use of menthol cigarettes as preferred/regular brand (defined as using \>20% of the time). 2. Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies). 3. Enrollment or plans to enroll in a smoking cessation program in the next month. 4. Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm). Alcohol/Drugs 1. History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. 2. Current alcohol consumption that exceeds 25 standard drinks/week. Medical 1. Women who are pregnant, planning a pregnancy, and/or lactating. 2. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the PI and eligibility will be determined on a case-by-case basis. 3. Color blindness. 4. Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis. Psychiatric As determined by self-report: 1. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia. 2. Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible. Other Additionally, participants may be deemed ineligible for any of the following general reasons at any point throughout the study, as well as during the initial telephone screen, at the discretion of the PI: * Significant non-compliance with protocol and/or study design. * Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data. * Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance.

Design outcomes

Primary

MeasureTime frameDescription
Carbon Monoxide (CO) BoostSession 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.
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)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).
Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)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).
Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)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).
Correct Beliefs About Reduced RisksSession 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.
Perceived Health Risks Summary ScoreSession 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.
Product Harshness (Subjective Rating Subscale 1)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.
Smoking Satisfaction (Subjective Rating Subscale 2)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.
Positive Sensory Experience (Subjective Rating Subscale 3)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.
Cleanliness (Subjective Rating Subscale 4)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.

Secondary

MeasureTime frameDescription
IntensitySession 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Light Pack Color
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).
21
Dark Pack Color
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).
19
Total40

Baseline characteristics

CharacteristicDark Pack ColorTotalLight Pack Color
Age, Continuous45.0 years
STANDARD_DEVIATION 13
46.1 years
STANDARD_DEVIATION 11.7
47.0 years
STANDARD_DEVIATION 10.7
Cigarettes per day15.6 cigarettes per day
STANDARD_DEVIATION 7.7
14.3 cigarettes per day
STANDARD_DEVIATION 6.2
13.1 cigarettes per day
STANDARD_DEVIATION 4.4
Nicotine dependence5.0 units on a scale
STANDARD_DEVIATION 2.6
4.9 units on a scale
STANDARD_DEVIATION 2.1
4.9 units on a scale
STANDARD_DEVIATION 1.7
Race/Ethnicity, Customized
White vs. Other Categories
Non-White
5 Participants10 Participants5 Participants
Race/Ethnicity, Customized
White vs. Other Categories
White
14 Participants30 Participants16 Participants
Sex: Female, Male
Female
8 Participants19 Participants11 Participants
Sex: Female, Male
Male
11 Participants21 Participants10 Participants
Years smoking regularly27.7 years
STANDARD_DEVIATION 16.1
28.9 years
STANDARD_DEVIATION 13.7
29.9 years
STANDARD_DEVIATION 11.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Carbon Monoxide (CO) Boost

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorCarbon Monoxide (CO) BoostCharcoal-filtered cigarette4.6 parts per millionStandard Error 0.7
Light Pack ColorCarbon Monoxide (CO) BoostNon-charcoal filtered cigarette5.0 parts per millionStandard Error 0.7
Dark Pack ColorCarbon Monoxide (CO) BoostCharcoal-filtered cigarette3.6 parts per millionStandard Error 0.7
Dark Pack ColorCarbon Monoxide (CO) BoostNon-charcoal filtered cigarette2.4 parts per millionStandard Error 0.7
Primary

Cleanliness (Subjective Rating Subscale 4)

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorCleanliness (Subjective Rating Subscale 4)Charcoal filtered cigarette72.4 score on a scaleStandard Error 5.8
Light Pack ColorCleanliness (Subjective Rating Subscale 4)Non-charcoal filtered cigarette70.5 score on a scaleStandard Error 5.5
Dark Pack ColorCleanliness (Subjective Rating Subscale 4)Charcoal filtered cigarette47.7 score on a scaleStandard Error 6.1
Dark Pack ColorCleanliness (Subjective Rating Subscale 4)Non-charcoal filtered cigarette49.3 score on a scaleStandard Error 5.8
Primary

Correct Beliefs About Reduced Risks

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorCorrect Beliefs About Reduced RisksCharcoal filtered cigarette3.8 score on a scaleStandard Error 0.6
Light Pack ColorCorrect Beliefs About Reduced RisksNon-charcoal filtered cigarette2.9 score on a scaleStandard Error 0.6
Dark Pack ColorCorrect Beliefs About Reduced RisksCharcoal filtered cigarette3.8 score on a scaleStandard Error 0.6
Dark Pack ColorCorrect Beliefs About Reduced RisksNon-charcoal filtered cigarette3.2 score on a scaleStandard Error 0.6
Primary

Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)

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).

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorNumber of Puffs Taken (Video-scored Smoking Behavior Outcome 1)Charcoal filtered cigarette15.8 puffsStandard Error 1.8
Light Pack ColorNumber of Puffs Taken (Video-scored Smoking Behavior Outcome 1)Non-charcoal filtered cigarette19.1 puffsStandard Error 2.3
Dark Pack ColorNumber of Puffs Taken (Video-scored Smoking Behavior Outcome 1)Charcoal filtered cigarette16.7 puffsStandard Error 1.9
Dark Pack ColorNumber of Puffs Taken (Video-scored Smoking Behavior Outcome 1)Non-charcoal filtered cigarette19.6 puffsStandard Error 2.4
Primary

Perceived Health Risks Summary Score

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorPerceived Health Risks Summary ScoreCharcoal-filtered cigarette5.6 score on a scaleStandard Error 0.3
Light Pack ColorPerceived Health Risks Summary ScoreNon-charcoal filtered cigarette5.3 score on a scaleStandard Error 0.3
Dark Pack ColorPerceived Health Risks Summary ScoreCharcoal-filtered cigarette5.4 score on a scaleStandard Error 0.3
Dark Pack ColorPerceived Health Risks Summary ScoreNon-charcoal filtered cigarette5.3 score on a scaleStandard Error 0.3
Primary

Positive Sensory Experience (Subjective Rating Subscale 3)

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorPositive Sensory Experience (Subjective Rating Subscale 3)Charcoal filtered cigarette59.3 score on a scaleStandard Error 5.2
Light Pack ColorPositive Sensory Experience (Subjective Rating Subscale 3)Non-charcoal filtered cigarette48.4 score on a scaleStandard Error 5.2
Dark Pack ColorPositive Sensory Experience (Subjective Rating Subscale 3)Charcoal filtered cigarette47.5 score on a scaleStandard Error 5.4
Dark Pack ColorPositive Sensory Experience (Subjective Rating Subscale 3)Non-charcoal filtered cigarette48.1 score on a scaleStandard Error 5.4
Primary

Product Harshness (Subjective Rating Subscale 1)

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorProduct Harshness (Subjective Rating Subscale 1)Charcoal filtered cigarette42.1 score on a scaleStandard Error 4.4
Light Pack ColorProduct Harshness (Subjective Rating Subscale 1)Non-charcoal filtered cigarette24.7 score on a scaleStandard Error 4.7
Dark Pack ColorProduct Harshness (Subjective Rating Subscale 1)Charcoal filtered cigarette42.6 score on a scaleStandard Error 4.6
Dark Pack ColorProduct Harshness (Subjective Rating Subscale 1)Non-charcoal filtered cigarette26.2 score on a scaleStandard Error 5
Primary

Smoking Satisfaction (Subjective Rating Subscale 2)

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorSmoking Satisfaction (Subjective Rating Subscale 2)Charcoal filtered cigarette65.8 score on a scaleStandard Error 4.2
Light Pack ColorSmoking Satisfaction (Subjective Rating Subscale 2)Non-charcoal filtered cigarette43.0 score on a scaleStandard Error 4.9
Dark Pack ColorSmoking Satisfaction (Subjective Rating Subscale 2)Charcoal filtered cigarette55.9 score on a scaleStandard Error 4.4
Dark Pack ColorSmoking Satisfaction (Subjective Rating Subscale 2)Non-charcoal filtered cigarette36.2 score on a scaleStandard Error 5.2
Primary

Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)

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).

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorTotal Interpuff Interval (Video-scored Smoking Behavior Outcome 3)Charcoal filtered cigarette257.7 secondsStandard Error 28.9
Light Pack ColorTotal Interpuff Interval (Video-scored Smoking Behavior Outcome 3)Non-charcoal filtered cigarette267.9 secondsStandard Error 28.8
Dark Pack ColorTotal Interpuff Interval (Video-scored Smoking Behavior Outcome 3)Charcoal filtered cigarette290.4 secondsStandard Error 30.3
Dark Pack ColorTotal Interpuff Interval (Video-scored Smoking Behavior Outcome 3)Non-charcoal filtered cigarette275.0 secondsStandard Error 30.3
Primary

Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)

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).

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorTotal Puffing Duration (Video-scored Smoking Behavior Outcome 2)Charcoal filtered cigarette30.4 secondsStandard Error 4.3
Light Pack ColorTotal Puffing Duration (Video-scored Smoking Behavior Outcome 2)Non-charcoal filtered cigarette41.4 secondsStandard Error 6.1
Dark Pack ColorTotal Puffing Duration (Video-scored Smoking Behavior Outcome 2)Charcoal filtered cigarette32.6 secondsStandard Error 4.5
Dark Pack ColorTotal Puffing Duration (Video-scored Smoking Behavior Outcome 2)Non-charcoal filtered cigarette41.2 secondsStandard Error 6.4
Secondary

Intensity

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.

Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

ArmMeasureGroupValue (MEAN)Dispersion
Light Pack ColorIntensityCharcoal-filtered cigarette15.2 cigarettes per dayStandard Error 2.5
Light Pack ColorIntensityNon-charcoal filtered cigarette12.7 cigarettes per dayStandard Error 2.5
Dark Pack ColorIntensityCharcoal-filtered cigarette19.7 cigarettes per dayStandard Error 2.7
Dark Pack ColorIntensityNon-charcoal filtered cigarette18.8 cigarettes per dayStandard Error 2.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026