Perceptions of Vaping Products Among Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of metatine and nicotine e-cigarettes
研究概览
简要总结
This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.
详细描述
PRIMARY OBJECTIVES:
I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.
II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.
III. Determine the impact of metatine on e-cigarette puffing behavior (topography).
OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21-34 years
- •Current nicotine EC user (defined as ≥ weekly use over the past 3 months)
- •Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions
- •Read and speak English
排除标准
- •Recently coronavirus disease 2019 (COVID-19) positive (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- •History of cardiac event or distress within the past 3 months
- •Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days
- •Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
- •Have hemophilia or another type of bleeding disorder
- •Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability
研究组 & 干预措施
Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
干预措施: Biospecimen Collection (Other)
Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
干预措施: Survey Administration (Other)
Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
干预措施: Nicotine E-cigarette (Other)
6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
干预措施: Survey Administration (Other)
6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
干预措施: Vaping Topography (Behavioral)
6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
干预措施: 6-methyl-nicotine (metatine) e-cigarette (Other)
Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
干预措施: Vaping Topography (Behavioral)
Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
干预措施: Participant's Own Preferred E-cigarette (Other)
Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
干预措施: Biospecimen Collection (Other)
Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
干预措施: Survey Administration (Other)
Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
干预措施: Vaping Topography (Behavioral)
6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
干预措施: Biospecimen Collection (Other)
结局指标
主要结局
Pharmacokinetics of metatine and nicotine e-cigarettes
时间窗: Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session
Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.
Sensory perceptions of EC vaping experience
时间窗: Minute 5 of vaping session, Minute 30 of vaping session
Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).
Relief of withdrawal symptoms
时间窗: Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session
Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.
Pharmacokinetics of metatine and nicotine e-cigarettes
时间窗: Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session
Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.
E-cigarette puffing behavior
时间窗: Week 1, Week 2, Week 3
E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.
Appeal ratings
时间窗: Minute 5 of vaping session, Minute 30 of vaping session
Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100).
Sensory perceptions of EC vaping experience
时间窗: Minute 5 of vaping session, Minute 30 of vaping session
Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).
Sensory ratings
时间窗: Minute 5 of vaping session, Minute 30 of vaping session
Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100).
Relief of withdrawal symptoms
时间窗: Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session
Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.
次要结局
未报告次要终点
研究者
Alayna Tackett
Principal Investigator
Ohio State University Comprehensive Cancer Center