The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.
详细描述
We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit.
Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant will be currently healthy individuals, between 18 and 40 years of age.
- •E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users
- •Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.
- •Do not meet any of the Exclusion criteria.
排除标准
- •Unwilling or unable to provide informed consent.
- •Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma.
- •Body weight less than 100 pounds or BMI >
- •Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
- •Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
- •Pregnant or lactating women.
- •Prisoners and other vulnerable populations.
- •Anyone that PI thinks is unsafe to participate in the study.
研究组 & 干预措施
0 mg nicotine
E-cigarette with 0 mg nicotine
干预措施: Prazosin (Drug)
18 mg nicotine
E-cigarette with 18 mg nicotine
干预措施: Prazosin (Drug)
9 mg nicotine
E-cigarette with 9 mg nicotine
干预措施: Prazosin (Drug)
结局指标
主要结局
Endothelial function
时间窗: Change between baseline and post exposure 20-30 mins
Flow mediated dilatation
次要结局
- Heart rate(Change between baseline and post exposure 5,10, 30, 60, 120 mins)
- Blood pressure(Change between baseline and post exposure 5,10, 30, 60, 120 mins)
- Heart Rate Variability(Change between baseline and post exposure 20 mins)
- Nicotine levels in plasma(Change between Baseline and over 2 hours)
研究者
Affan B. Irfan
Principal investigator
University of Louisville