Completed
SKY Pilot

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Charcoal-filtered cigarette

+ Non-charcoal filtered cigarette
Other
Who is being recruted

From 21 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2022
See protocol details

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 10, 2022Actual date on which the first participant was enrolled.

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).

Official TitleAcute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure 
NCT05157048
Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the dark pack color condition will be given Natural American Spirit Black packs.

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.

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.
Group II
Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the light pack color condition will be given Natural American Spirit Sky packs.

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.

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.
Study Objectives
Primary Objectives

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).

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).

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).

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 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.

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.

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.

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.

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.

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.
Secondary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Center for Interdisciplinary Research on Nicotine Addiction, University of PennsylvaniaPhiladelphia, United StatesSee the location
CompletedOne Study Center
;