The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
- Conditions
- Cigarette Smoking ToxicityNicotineAcute Cardiovascular Disease
- Interventions
- Registration Number
- NCT03010995
- Lead Sponsor
- University of Louisville
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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 >40.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 9 mg nicotine Prazosin E-cigarette with 9 mg nicotine 18 mg nicotine Prazosin E-cigarette with 18 mg nicotine 0 mg nicotine Prazosin E-cigarette with 0 mg nicotine
- Primary Outcome Measures
Name Time Method Endothelial function Change between baseline and post exposure 20-30 mins Flow mediated dilatation
- Secondary Outcome Measures
Name Time Method 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
Nicotine levels in plasma Change between Baseline and over 2 hours Detect plasma nicotine levels
Trial Locations
- Locations (1)
University of Louisville
🇺🇸Louisville, Kentucky, United States