Last reviewed · How we verify

NCT05157048: SKY Pilot

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

Completed NA Results posted Last updated 7 November 2024
What this trial tests

NA trial testing Charcoal-filtered cigarette in Smoking Behaviors in 42 participants. Completed in 14 February 2023.

Timeline
10 March 2022
Primary endpoint
14 February 2023
14 February 2023

Quick facts

Lead sponsorAbramson Cancer Center at Penn Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposeprevention
Enrollment42
Start date10 March 2022
Primary completion14 February 2023
Estimated completion14 February 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

Adults 21 to 60, any sex, with Smoking Behaviors. 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.

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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color15.8± 1.8
Dark Pack Color16.7± 1.9
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color19.1± 2.3
Dark Pack Color19.6± 2.4
Total Puffing Duration (Video-scored Smoking Behavior Outcome 2) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color30.4± 4.3
Dark Pack Color32.6± 4.5
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color41.4± 6.1
Dark Pack Color41.2± 6.4
Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color257.7± 28.9
Dark Pack Color290.4± 30.3
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color267.9± 28.8
Dark Pack Color275.0± 30.3
Correct Beliefs About Reduced Risks Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color3.8± 0.6
Dark Pack Color3.8± 0.6
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color2.9± 0.6
Dark Pack Color3.2± 0.6
Perceived Health Risks Summary Score Primary · 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.

Charcoal-filtered cigarette
GroupValue95% CI
Light Pack Color5.6± 0.3
Dark Pack Color5.4± 0.3
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color5.3± 0.3
Dark Pack Color5.3± 0.3
Product Harshness (Subjective Rating Subscale 1) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color42.1± 4.4
Dark Pack Color42.6± 4.6
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color24.7± 4.7
Dark Pack Color26.2± 5.0
Smoking Satisfaction (Subjective Rating Subscale 2) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color65.8± 4.2
Dark Pack Color55.9± 4.4
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color43.0± 4.9
Dark Pack Color36.2± 5.2
Positive Sensory Experience (Subjective Rating Subscale 3) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color59.3± 5.2
Dark Pack Color47.5± 5.4
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color48.4± 5.2
Dark Pack Color48.1± 5.4
Cleanliness (Subjective Rating Subscale 4) Primary · 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

Charcoal filtered cigarette
GroupValue95% CI
Light Pack Color72.4± 5.8
Dark Pack Color47.7± 6.1
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color70.5± 5.5
Dark Pack Color49.3± 5.8
Carbon Monoxide (CO) Boost Primary · 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.

Charcoal-filtered cigarette
GroupValue95% CI
Light Pack Color4.6± 0.7
Dark Pack Color3.6± 0.7
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color5.0± 0.7
Dark Pack Color2.4± 0.7
Intensity Secondary · 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.

Charcoal-filtered cigarette
GroupValue95% CI
Light Pack Color15.2± 2.5
Dark Pack Color19.7± 2.7
Non-charcoal filtered cigarette
GroupValue95% CI
Light Pack Color12.7± 2.5
Dark Pack Color18.8± 2.7

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Acute effects of charcoal filters and package color on cigarette perceptions and use behaviors: Results from a randomized pilot study examining Natural American Spirit "Sky".
    Mercincavage M, Waugh LK, Gratale S, Wackowski O, et al · · 2024 · PMID 38198898 · DOI 10.1016/j.drugalcdep.2024.111080

Verify or expand the search:

Other recruiting trials for Smoking Behaviors

Currently open trials in the same condition.

Other Abramson Cancer Center at Penn Medicine 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/NCT05157048.

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