The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Plasma nicotine concentration (ng/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
100 PG: 0 VG
干预措施: ECIG liquid vehicles (Other)
0 PG: 100 VG
干预措施: ECIG liquid vehicles (Other)
30 PG: 70 VG
干预措施: ECIG liquid vehicles (Other)
50 PG: 50 VG
干预措施: ECIG liquid vehicles (Other)
70 PG: 30 VG
干预措施: ECIG liquid vehicles (Other)
结局指标
主要结局
Plasma nicotine concentration (ng/ml)
时间窗: 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.
taken via intravenous catheter
Withdrawal suppression items on a visual analog scale
时间窗: 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.
provided using computerized questionnaire
次要结局
未报告次要终点
