Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Product Appeal
研究概览
简要总结
This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.
详细描述
PRIMARY OBJECTIVES:
I. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.
SECONDARY OBJECTIVES:
I. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.
II. Evaluate the effect of perceived harm on IQOS use behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 21-65 years
- •Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)
- •Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit
- •Willing to bring UBC to each study visit
- •Read, write and speak English
排除标准
- •Current use of other non-combustible nicotine products (e.g., electronic [e]-cigarettes, HTPs; [defined as ≥ 5 days weekly use in the past 30 days])
- •Planning to quit nicotine use and/or use of any smoking cessation medication in the past 30 days
- •Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)
- •Self-reported unstable or significant psychiatric conditions (past/stable conditions will be allowed)
- •History of cardiac event or distress within the past 3 months
- •Deaf, hard of hearing, or have a severe motor disability
- •Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)
研究组 & 干预措施
Arm II (UBC, IQOS HeatSticks)
Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.
干预措施: Smoking Behavioral Research (IQOS) (Behavioral)
Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])
Participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their UBC ad lib over 60 minutes during laboratory visit 2.
干预措施: Smoking Behavioral Research (IQOS) (Behavioral)
Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])
Participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their UBC ad lib over 60 minutes during laboratory visit 2.
干预措施: Smoking Behavioral Research (UBC) (Behavioral)
Arm II (UBC, IQOS HeatSticks)
Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.
干预措施: Smoking Behavioral Research (UBC) (Behavioral)
结局指标
主要结局
Product Appeal
时间窗: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Participants will complete the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.
Product Sensory Attributes
时间窗: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Participants will rate sensory attributes using the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for sensory attributes such as harshness, coolness, sweetness, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater harshness, coolness, sweetness, etc.
Economic demand breakpoint
时间窗: Minute 60 of product use session
The price point at which a participant is no longer willing to pay for a stick of the study product will be determined by using a cigarette purchase task questionnaire.
Satisfaction and psychological reward
时间窗: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Satisfaction and psychological reward of study product use will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using the study product on a scale from 0 (Not at all) - 6 (Extremely).
Abuse Liability Via Puff Topography - Total Smoking Time
时间窗: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Abuse Liability Via Puff Topography - Average Puff Duration
时间窗: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Abuse Liability Via Puff Topography - Average Flow Rate
时间窗: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
时间窗: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Abuse Liability Via Puff Topography - Average Puff Volume
时间窗: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Craving/withdrawal
时间窗: Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session
Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)
次要结局
- Spirometry FEV1(Minute 0 before start of product use session and minute 60 of product use session)
- Spirometry FVC(Minute 0 before start of product use session, Minute 60 of product use session)
- Spirometry FEV1/FVC(Minute 0 before start of product use session, Minute 60 of product use session)
- Used filter count(Minute 60 of product use session)
- Harm Perception(Minute 60 of product use session)
研究者
Alayna Tackett
Principal Investigator
Ohio State University Comprehensive Cancer Center