Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Arousal
研究概览
简要总结
This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.
详细描述
PRIMARY OBJECTIVES:
I. Examine the effects of nicotine concentration and source claims on engagement with ONP packaging using laboratory-based psychophysiological assessment.
II. Examine the effects of nicotine concentration and source claims on participant self-reported ONP perceptions, behavioral intentions, and ONP trial.
This is an experimental behavioral study. Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adult susceptible non-users aged 18-24 who have never used ONPs and have never used but are susceptible to using either:
- •combustible tobacco only (cigarettes, cigars, waterpipe)
- •non-combustible tobacco only (ST, ECs, heated tobacco products)
- •or both combustible and non-combustible tobacco (i.e., dual susceptibility)
- •Adult tobacco users aged 18-65 who have never used ONPs OR have used ONPs >3 months ago and 10 times or less in their lifetime. All adult tobacco users must also be:
- •exclusive combustible tobacco users
- •exclusive non-combustible tobacco users
- •dual users
- •For adult tobacco users, we will define current use as use of combustible and/or non-combustible tobacco every day or some days for 6 months or longer
- •Willing and able to complete an in-person lab visit.
排除标准
- •Age < 18 or > 65
- •Are not susceptible non-users or current tobacco users
- •Are unwilling or unable to complete and in person lab visit.
- •Have used ONPs within the past 3 months
- •Have used ONPs more than 10 times in their lifetime
研究组 & 干预措施
Nicotine Concentration: None Displayed; Nicotine Source Claim 1
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: None Displayed; Nicotine Source Claim 2
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: None Displayed; Nicotine Source Claim 3
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: Low; Nicotine Source Claim 1
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: Low; Nicotine Source Claim 2
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: Low; Nicotine Source Claim 3
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: High; Nicotine Source Claim 1
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: High; Nicotine Source Claim 2
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
Nicotine Concentration: High; Nicotine Source Claim 3
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
干预措施: 3x3 between-subjects experimental exposure (Behavioral)
结局指标
主要结局
Arousal
时间窗: 1 day (Single Time Point: During Exposure)
Arousal is an indicator of physiological activation of the sympathetic nervous system and will be measured by skin conductance using Shimmer3 Galvanic Skin Response EDA sensors sampled at 128 Hz
Visual Attention - Number of Fixations
时间窗: 1 day (Single Time Point: During Exposure)
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be number of fixations (i.e., saccades) to AOIs.
Recall
时间窗: 1 day (Single Time Point: During Exposure)
We will capture unaided recall, a measure of storage in memory, via 3 open ended questions on a questionnaire pertaining to nicotine concentration, brand names, and source information corresponding to conditions to which participants are randomized. Responses will be coded, and coding reliability will be established, to create a score with higher values reflecting better recall of information about nicotine dimensions in the stimuli.
ONP Intentions
时间窗: 1 day (Single Time Point: During Exposure)
We will assess curiosity, interest, and likelihood of using ONPs post-exposure. These are valid predictors of future use of novel tobacco and nicotine products among never users. Items are on a 1-7 scale, have excellent reliability, and are combined to create an overall ONP intentions score.
ONP Perceptions Relative to Other Products
时间窗: 1 day (Single Time Point: During Exposure)
We will also capture perceived harm and addictiveness of ONPs relative to cigarettes, smokeless tobacco, and electronic cigarettes using valid items on a 1-5 response scale.
Cognitive Attention
时间窗: 1 day (Single Time Point: During Exposure)
Conceptualized as the cognitive resources allocated to encode a message into working memory, attention will be operationalized as the difference in heart rate (HR) between a baseline period prior to each pack image and during each second of the pack image exposure assessed with ECG. Beats per minute (BPM) will be collected with the Shimmer3 sampled at 512 Hz. This is an established psychophysiological measure of cognitive resources devoted to stimuli processing.
ONP Perceptions
时间窗: 1 day (Single Time Point: During Exposure)
We will capture perceptions of ONPs with 7 items that align with expert recommendations for assessing cognitive and affective aspects of tobacco risk perceptions. Items will assess perceived risk of health harm from ONPs, perceived risk of addiction from ONPs, worry about harm, and worry about addiction. The items are on a 1-7 response scale, have excellent reliability, and are averaged to create an overall score.
Visual Attention - Dwell Time
时间窗: 1 day (Single Time Point: During Exposure)
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be dwell time on AOIs.
Visual Attention - Time to First Fixation
时间窗: 1 day (Single Time Point: During Exposure)
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be time to first fixation on AOIs.
次要结局
未报告次要终点
研究者
Darren Mays
Principal Investigator
Ohio State University Comprehensive Cancer Center