The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- University of Louisville
- Locations
- 1
- Primary Endpoint
- Endothelial function
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
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 >
- •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.
Arms & Interventions
0 mg nicotine
E-cigarette with 0 mg nicotine
Intervention: Prazosin (Drug)
18 mg nicotine
E-cigarette with 18 mg nicotine
Intervention: Prazosin (Drug)
9 mg nicotine
E-cigarette with 9 mg nicotine
Intervention: Prazosin (Drug)
Outcomes
Primary Outcomes
Endothelial function
Time Frame: Change between baseline and post exposure 20-30 mins
Flow mediated dilatation
Secondary Outcomes
- 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)
Investigators
Affan B. Irfan
Principal investigator
University of Louisville