Smoking BehaviorsSKY PilotNCT05157048
Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
A study testing Charcoal-filtered cigarette and Non-charcoal filtered cigarette in people with Smoking Behaviors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Charcoal-filtered cigarette and Non-charcoal filtered cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
- Smoking Behavior
- Use of menthol cigarettes as preferred/regular brand (defined as using >20% of the time).
- Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies).
- Enrollment or plans to enroll in a smoking cessation program in the next month.
- Provide an initial Carbon Monoxide (CO) reading < 5 parts per million (ppm).
Show all 23Show fewer
- Alcohol/Drugs
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Medical
- Women who are pregnant, planning a pregnancy, and/or lactating.
- 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.
- Color blindness.
- 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:
- Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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).
Read the 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).
- Conditions
- Smoking Behaviors
- Being tested
- Charcoal-filtered cigarette, Non-charcoal filtered cigarette
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charcoal-filtered cigaretteOther
Also called Product
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.
Non-charcoal filtered cigaretteOther
Also called Product
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 group | Role | What they receive |
|---|---|---|
| Light pack color | 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. Receives: Other: Charcoal-filtered cigarette; Other: Non-charcoal filtered cigarette |
| Dark pack color | 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. Receives: Other: Charcoal-filtered cigarette; Other: Non-charcoal filtered cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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).
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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).
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
Secondary outcomes (1)
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.
Measured: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start10 Mar 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Single-session study utilizing a 2 x 2 mixed factorial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Strasser, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157048
- Sponsor's protocol ID
- UPCC 05021
- Other IDs
- IRB 849152
- Acronym
- SKY Pilot
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2021
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mercincavage M, Waugh LK, Gratale S, Wackowski O, Pearson JL, House K, O'Connor R, Strasser AA. 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". Drug Alcohol Depend. 2024 Feb 1;255:111080. doi: 10.1016/j.drugalcdep.2024.111080. Epub 2024 Jan 5.
PubMed 38198898
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
- ClinicalTrials.gov ID
- NCT05157048
- Acronym / sponsor ID
- SKY Pilot / UPCC 05021
- Conditions
- Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-session study utilizing a 2 x 2 mixed factorial design
| Arm | Type | Receives |
|---|---|---|
| Light pack color | Experimental | Other: Charcoal-filtered cigarette, Other: Non-charcoal filtered cigaretteParticipants 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. |
| Dark pack color | Experimental | Other: Charcoal-filtered cigarette, Other: Non-charcoal filtered cigaretteParticipants 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
- Smoking Behavior
- Use of menthol cigarettes as preferred/regular brand (defined as using >20% of the time).
- Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies).
- Enrollment or plans to enroll in a smoking cessation program in the next month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Charcoal-filtered cigaretteAlso: ProductParticipants 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. | Other | Dark pack color, Light pack color |
| Non-charcoal filtered cigaretteAlso: ProductParticipants 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. | Other | Dark pack color, Light pack color |
Primary outcome
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
Time frame: 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)
Time frame: 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)
Time frame: 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 Risks
Time frame: 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.
Perceived Health Risks Summary Score
Time frame: 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.
Product Harshness (Subjective Rating Subscale 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Carbon Monoxide (CO) Boost
Time frame: 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.
1 secondary outcome
Intensity
Time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38198898Mercincavage M, Waugh LK, Gratale S, Wackowski O, Pearson JL, House K, O'Connor R, Strasser AA. 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". Drug Alcohol Depend. 2024 Feb 1;255:111080. doi: 10.1016/j.drugalcdep.2024.111080. Epub 2024 Jan 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charcoal-filtered cigarette and Non-charcoal filtered cigarette in people with Smoking Behaviors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1) (time frame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.