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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cigarette Smoking Toxicity, Nicotine, Acute Cardiovascular Disease

Intervention / Treatment
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* Drug: Prazosin


Participation Criteria
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Eligibility Criteria
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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 >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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 18 mg nicotine<br>E-cigarette with 18 mg nicotine | Drug: Prazosin<br>* Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes<br>|
| Active Comparator: 9 mg nicotine<br>E-cigarette with 9 mg nicotine | Drug: Prazosin<br>* Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes<br>|
| Placebo Comparator: 0 mg nicotine<br>E-cigarette with 0 mg nicotine | Drug: Prazosin<br>* Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow mediated dilatation | Change between baseline and post exposure 20-30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate monitor | Change between baseline and post exposure 5,10, 30, 60, 120 mins | 
| Blood pressure | Blood pressure monitor | Change between baseline and post exposure 5,10, 30, 60, 120 mins | 
| Heart Rate Variability | SphygmoCor HRV system SCOR-Hx | Change between baseline and post exposure 20 mins | 
| Nicotine levels in plasma | Detect plasma nicotine levels | Change between Baseline and over 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarette, endothelial function