Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to both the marketing and cigarette condition manipulations
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
- •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.
研究组 & 干预措施
Light pack color
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.
干预措施: Charcoal-filtered cigarette (Other)
Light pack color
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.
干预措施: Non-charcoal filtered cigarette (Other)
Dark pack color
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.
干预措施: Charcoal-filtered cigarette (Other)
Dark pack color
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.
干预措施: Non-charcoal filtered cigarette (Other)
结局指标
主要结局
Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Intensity(Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition))
研究者
Andrew Strasser
Research Professor of Psychiatry
Abramson Cancer Center at Penn Medicine