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

NCT05157048 | Completed Results

• 2 other identifiers: UPCC 05021IRB 849152
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Behaviors

Outcome Measures

Primary Outcomes (10)

• 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).

  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)

Secondary Outcomes (1)

• Intensity

  Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)

Study Arms (2)

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.

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.

Other: Charcoal-filtered cigarette; Other: Non-charcoal filtered cigarette

Interventions

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.

Also known as: Product

Dark pack color; Light pack color

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.

Also known as: Product

Dark pack color; Light pack color

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Victoria Constantine
• Organization: University of Pennsylvania

vmcl@pennmedicine.upenn.edu

215-746-4069

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to both the marketing and cigarette condition manipulations
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Psychiatry

Model Details: Single-session study utilizing a 2 x 2 mixed factorial design

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 14, 2021
• Study Start: March 10, 2022
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-08

Locations

US (1)