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

Not Applicable

Completed

Conditions: Smoking Behaviors

Interventions: Other: Cigarette A
Other: Cigarette B

Registration Number: NCT05157048

Lead Sponsor: Abramson Cancer Center at Penn Medicine

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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

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).

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Marketing condition A	Cigarette B	Participants will be randomized to a marketing condition.
Marketing condition B	Cigarette A	Participants will be randomized to a marketing condition.
Marketing condition A	Cigarette A	Participants will be randomized to a marketing condition.
Marketing condition B	Cigarette B	Participants will be randomized to a marketing condition.

Primary Outcome Measures

Name	Time	Method
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Smoking behaviors were assessed using video-scored measures of smoking topography (i.e., puffing behavior), including number of puffs taken, total puffing duration, and total interpuff interval (time between puffs). Briefly, research staff used a digital timestamp feature in an open-source video editing software to estimate start and end times for individual puffs based on various physical cues (e.g., inhaling, glowing cigarette tip), prioritizing overall puffing behaviors (e.g., multiple occurrences of tip glowing without removing the cigarette from the mouth \["stutter puffs"\] were treated as a single puff).
Correct Beliefs About Reduced Risks	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	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)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Subjective ratings were assessed with THE Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Smoking Satisfaction (Subjective Rating Subscale 2)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Positive Sensory Experience (Subjective Rating Subscale 3)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Cleanliness (Subjective Rating Subscale 4)	Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)	Subjective ratings were assessed with the Cigarette Rating Scale, a 100 mm visual analog scale used by the tobacco industry and our laboratory to assess 14 characteristics; higher scores generally indicate more favorable ratings (e.g., taste: 0 = "bad," 100 = "good"). We examined mean scores from three subscales generated from these items to assess domains of product harshness, smoking satisfaction, and positive sensory experience. We also explored a fourth 'cleanliness' subscale created by averaging two exploratory items assessing "chemical vs. tobacco taste" and "dirty vs. clean body feeling" based on qualitative data from a related pilot study. All subscale scores have a range of 0-100, with higher scores generally indicative of more favorable ratings.
Carbon Monoxide (CO) Boost	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.

Secondary Outcome Measures

Name	Time	Method
Intensity	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.

Trial Locations

Locations (1): Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
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Philadelphia, Pennsylvania, United States