The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
2018年5月1日 更新者:Virginia Commonwealth University
This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin.
Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant).
Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.
研究概览
详细说明
Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity.
However, very little is known about ECIGs, including what factors may make them more likely to be used and abused.
Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability.
Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions.
Specifically, higher proportions of PG result in greater nicotine yields.
However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously.
The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users.
Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.
研究类型
介入性
注册 (实际的)
41
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Virginia
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Richmond、Virginia、美国、23298
- Clinical Behavioral Pharmacology Laboratory
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants must use ≥1 ml of ECIG solution daily
- Must use ECIG solution with a nicotine concentration ≥12 mg/ml
- Must have used an ECIG for ≥3 months
- Must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session.
Exclusion Criteria:
- History of chronic disease or psychiatric condition
- Regular use of a prescription medication
- Marijuana use >10 and alcohol use >25 days in the past 30
- Any other illicit drug use (e.g., cocaine, opioids) in the past 30 days.
- Positive test for pregnancy (by urinalysis)
- Daily use of >5 conventional tobacco cigarettes
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:0 PG: 100 VG
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The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
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实验性的:30 PG: 70 VG
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The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
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实验性的:50 PG: 50 VG
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The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
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实验性的:70 PG: 30 VG
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The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
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实验性的:100 PG: 0 VG
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The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Plasma nicotine concentration (ng/ml)
大体时间:Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
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taken via intravenous catheter
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Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
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Withdrawal suppression items on a visual analog scale
大体时间:Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
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provided using computerized questionnaire
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Collected at each of the 5 visits. Participants can complete up to 2 sessions/week. Thus the average time period to complete all 5 sessions is approximately 3 weeks. Each individual session is approximately 3 hours long.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Tory R Spindle, B.S.、Virginia Commonwealth University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年7月1日
初级完成 (实际的)
2017年5月16日
研究完成 (实际的)
2017年5月16日
研究注册日期
首次提交
2015年7月6日
首先提交符合 QC 标准的
2015年7月14日
首次发布 (估计)
2015年7月16日
研究记录更新
最后更新发布 (实际的)
2018年5月7日
上次提交的符合 QC 标准的更新
2018年5月1日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
其他研究编号
- HM20004850
- 1F31DA040319-01 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
ECIG liquid vehicles的临床试验
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University of California, Los AngelesTobacco Related Disease Research Program完全的
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Virginia Commonwealth UniversityNational Institute on Drug Abuse (NIDA)完全的
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Institut für Klinische Krebsforschung IKF GmbH...Roche Pharma AG招聘中