Vascular Effects of a Single Bout of Electronic Cigarette Use

NCT03209661 — Phase 1, Completed, 16 participants, University of Texas at Austin

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Registry	NCT03209661
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: single, other
Enrollment	16 (Actual)
Sponsor	University of Texas at Austin (Other)
Conditions	Arterial Stiffness
Interventions	E-cigarette, Nicotine 0%, Menthol Inhalant Product (Drug)
Dates	start 2017-04-28, primary completion 2018-08-01, completion 2018-08-31, first posted 2017-07-06, last updated 2018-10-11
Locations	1 site in United States

-Summary

Investigating the acute effects of a single use E-Cigarette upon vascular health.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
E-Cigarette 5.4% NBV	Active comparator	Drug: E-cigarette	Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.
E-Cigarette 0% NBV	Placebo comparator	Drug: Nicotine 0%	Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.
Menthol Inhaler	Placebo comparator	Drug: Menthol Inhalant Product	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.

E-cigarette (Drug), also known as Nicotine 5.4%: E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.
Nicotine 0% (Drug), also known as Placebo: E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.
Menthol Inhalant Product (Drug), also known as Placebo: Menthol inhaler will be administered to determine the effects on vascular function.

+Outcome measures

Primary outcomes

Changes in arterial stiffness and endothelial function with e-cigarette use. [Immediately Post, 1 hour, and 2 hour.]: Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction

+Eligibility

Sex: All, ages: 20 Years to 30 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Cardiovascular Aging Research Lab at UT Austin	Austin, Texas	United States

+Publications

Results publication: 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. PMID 31531991

+Investigators

Hirofumi Tanaka, Phd, Principal investigator, University of Texas

My Notes

Public

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