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Investigating the acute effects of a single use E-Cigarette upon vascular health.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette 5.4% NBV | Active Comparator | Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min. |
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| E-Cigarette 0% NBV | Placebo Comparator | Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min. |
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| Menthol Inhaler | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette | Drug | E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function. |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirofumi Tanaka, Phd | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Aging Research Lab at UT Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31531991 | Derived | Cossio R, Cerra ZA, Tanaka H. Vascular effects of a single bout of electronic cigarette use. Clin Exp Pharmacol Physiol. 2020 Jan;47(1):3-6. doi: 10.1111/1440-1681.13180. Epub 2019 Oct 7. |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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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.
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E-cigarettes being utilized are of the same brand and design. Additionally, the device will be covered by a sheath to ensure labeling is not visible to the subject.
| Nicotine 0% | Drug | E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function. |
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| Menthol Inhalant Product | Drug | Menthol inhaler will be administered to determine the effects on vascular function. |
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