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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 849152 | Other Identifier | Penn CTSRMC |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Charcoal-filtered cigarette | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
Smoking Behavior
Alcohol/Drugs
Medical
Psychiatric
As determined by self-report:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38198898 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Pack Color | All participants smoked two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject factor), in counterbalanced order. Participants were randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor). Those in the light pack condition received cigarettes in Natural American Spirit Sky packs. |
| FG001 | Dark Pack Color | All participants smoked two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter (within-subject factor), in counterbalanced order. Participants were randomized to receive study cigarettes in one of two pack color conditions: light or dark (between-subject factor). Those in the dark pack condition received cigarettes in Natural American Spirit Black packs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Error | puffs | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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Adverse event data were not collected as this study was comprised of a single session.
Adverse event data were not collected as this study was comprised of a single session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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This sample may not reflect the general smoking population or intended consumers of Sky; because we used commercial packages to examine their real-world marketing effects, we could not disentangle effects of color from other packaging elements; the low maximum price used in the purchase task limited the utility of this measure as an outcome; findings reflect reactions to charcoal-filtered cigarettes and their packaging after an acute, blinded one-time exposure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Constantine | University of Pennsylvania | 215-746-4069 | vmcl@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2022 | Feb 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Single-session study utilizing a 2 x 2 mixed factorial design
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Participants will be blinded to both the marketing and cigarette condition manipulations
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| Non-charcoal filtered cigarette | Other | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
| Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
| BG001 |
| 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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Cigarettes per day | Assessed using the question, "In the past 7 days, about how many cigarettes have you smoked per day?" | Mean | Standard Deviation | cigarettes per day |
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| Years smoking regularly | Mean | Standard Deviation | years |
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| Nicotine dependence | Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD), a 6-item, self-report measure of nicotine dependence. Items are summed to a score ranging from 0-10, with greater scores indicating greater nicotine dependence. | Mean | Standard Deviation | units on a scale |
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| OG001 | Dark Pack Color | All participants will smoke two visually identical cigarettes varying in filter type (within-subject condition: charcoal and non-charcoal filter), in counterbalanced order. Participants will be randomized to receive cigarettes in one of two pack colors (between-subject-condition: light or dark). |
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| 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). | Posted | Mean | Standard Error | seconds | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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). | Posted | Mean | Standard Error | seconds | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | score on a scale | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | parts per million | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 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. | Posted | Mean | Standard Error | cigarettes per day | Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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