Acute Cardiovascular Disease, Cigarette Smoking Toxicity, Nicotine
Conditions
Keywords
electronic cigarette, endothelial function
Brief summary
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.
Detailed description
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.
Interventions
DRUGPrazosin
Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
Sponsors
University of Louisville
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant will be currently healthy individuals, between 18 and 40 years of age. 2. 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 3. Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study. 4. Do not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Change between baseline and post exposure 20-30 mins | Flow mediated dilatation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine levels in plasma | Change between Baseline and over 2 hours | Detect plasma nicotine levels |
| Heart rate | Change between baseline and post exposure 5,10, 30, 60, 120 mins | Heart rate monitor |
| Blood pressure | Change between baseline and post exposure 5,10, 30, 60, 120 mins | Blood pressure monitor |
| Heart Rate Variability | Change between baseline and post exposure 20 mins | SphygmoCor HRV system SCOR-Hx |
Countries
United States
Outcome results
None listed