Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Subjective Questionnaires of Product Evaluation
研究概览
简要总结
This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption.
详细描述
PRIMARY OBJECTIVE:
I. To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking.
OUTLINE: Participants are randomized to 1 of 4 conditions.
CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
CONDITION II: Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21-69 years old
- •Currently smoking daily, at least 5 cigarettes per day, for the past year:
- •* Primarily using factory-made filtered cigarettes
- •Fair and above self-rated physical health (self-rated)
- •Fair and above self-rated mental health (self-rated)
- •Not planning to quit smoking in the next 30 days
- •Able to converse, read, and write in English
- •Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component
- •Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins)
- •Alcohol Use Disorders Identification Test (AUDIT)-C <7 (i.e., no problematic alcohol consumption)
- •Cannibis use less than or equal to 5 days in the past month
- •No other illegal drug use in the past month (allow for prescription)
- •Not pregnant or breastfeeding or planning to become pregnant during the study period
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Age < 21 or > 69
- •Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered
- •Planning to quit smoking in the next 30 days
- •Adults unable to consent
- •Minors (any persons under age 21)
- •Prisoners
- •Poor physical health by self-report
- •Poor mental health by self-report:
- •* Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress
- •AUDIT-C score >=7 (i.e. problematic alcohol consumption)
- •Cannabis use >5 days in past month
- •Other illegal drug use in past month
- •Pregnant or breastfeeding by self-report
- •No access to smartphone or videoconferencing
研究组 & 干预措施
Condition 1 (normal cigarettes)
Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Cigarette packaging (Other)
Condition 1 (normal cigarettes)
Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Data capture (Other)
Condition 1 (normal cigarettes)
Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Questionnaire administration (Other)
Condition II (cigarettes with neutral message)
Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Cigarette packaging (Other)
Condition II (cigarettes with neutral message)
Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Data capture (Other)
Condition II (cigarettes with neutral message)
Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
干预措施: Questionnaire administration (Other)
Condition III (cigarettes with compensation message)
Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Cigarette packaging (Other)
Condition III (cigarettes with compensation message)
Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Data capture (Other)
Condition III (cigarettes with compensation message)
Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Questionnaire administration (Other)
Condition IV cigarettes with blocking message
Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Cigarette packaging (Other)
Condition IV cigarettes with blocking message
Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Data capture (Other)
Condition IV cigarettes with blocking message
Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
干预措施: Questionnaire administration (Other)
结局指标
主要结局
Subjective Questionnaires of Product Evaluation
时间窗: At 2 weeks
Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely).
Readiness to Quit
时间窗: At 2 weeks
Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately.
Withdrawal
时间窗: At 2 weeks
Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items.
次要结局
- Level of Exhaled Carbon Monoxide (CO)(At 2 weeks)