Vascular Effects of a Single Bout of Electronic Cigarette Use

Study Overview
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Brief Summary
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Investigating the acute effects of a single use E-Cigarette upon vascular health.

Detailed Description
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Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the effects upon to measures of vascular health. These measures will include Cardio-Ankle Vascular Index and Flow Mediated Dilation.

Official Title
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Vascular Effects of a Single Bout of Electronic Cigarette Use

Conditions
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Arterial Stiffness

Intervention / Treatment
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* Drug: E-cigarette
* Drug: Nicotine 0%
* Drug: Menthol Inhalant Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy, with no cardiovascular or metabolic diseases. Additionally, is not a frequent smoker of any kind. Exclusion Criteria: Cardiovascular or Metabolic Diseases and/or regular smoker.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 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: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be asked to inhale one of three mediums; 5.4% NBV e-ciggarette, 0% NBV cigarette, and sham menthol inhaler (no vapor). Baseline measurements will be conducted upon arrival and followed immediately post inhalation, 1-hour post, and finally 2-hours post. All trials will require a minimum of 48 hours washout.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Cigarette 5.4% NBV<br>Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min. | Drug: E-cigarette<br>* E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.<br>* Other names: Nicotine 5.4%;|
| Placebo Comparator: E-Cigarette 0% NBV<br>Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min. | Drug: Nicotine 0%<br>* E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.<br>* Other names: Placebo;|
| Placebo Comparator: Menthol Inhaler<br>Subjects will be asked to inhale a sham methole inhaler (that looks identical in looks to E-cigarette) for 6 minutes. This arm is to control for a potential effect of menthole. | Drug: Menthol Inhalant Product<br>* Menthol inhaler will be administered to determine the effects on vascular function.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in arterial stiffness and endothelial function with e-cigarette use. | Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction | Immediately Post, 1 hour, and 2 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function