The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study



Status:Withdrawn
Conditions:Peripheral Vascular Disease, Smoking Cessation
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 40
Updated:7/28/2018
Start Date:March 13, 2018
End Date:July 24, 2018

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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.

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.

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.
We found this trial at
1
site
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Affan Irfan
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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