Clinical trial NCT03010995: The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
Official title: The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cigarette Smoking Toxicity
Nicotine
Acute Cardiovascular Disease
Keywords: electronic cigarette
endothelial function
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.
2. 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.
3. Body weight less than 100 pounds or BMI \>40.
4. Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
5. Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
6. Pregnant or lactating women.
7. Prisoners and other vulnerable populations.
8. Anyone that PI thinks is unsafe to participate in the study.

Primary outcomes:
measure: Endothelial function
timeFrame: Change between baseline and post exposure 20-30 mins
Secondary outcomes:
measure: Heart rate
timeFrame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
measure: Blood pressure
timeFrame: Change between baseline and post exposure 5,10, 30, 60, 120 mins
measure: Heart Rate Variability
timeFrame: Change between baseline and post exposure 20 mins
measure: Nicotine levels in plasma
timeFrame: Change between Baseline and over 2 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References: