Vascular Effects of a Single Bout of Electronic Cigarette Use

NCT ID: NCT03209661

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-08-31

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.

Conditions

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Arterial Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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E-Cigarette 5.4% NBV

Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.

Group Type ACTIVE_COMPARATOR

E-cigarette

Intervention Type DRUG

E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.

E-Cigarette 0% NBV

Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.

Group Type PLACEBO_COMPARATOR

Nicotine 0%

Intervention Type DRUG

E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.

Menthol Inhaler

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.

Group Type PLACEBO_COMPARATOR

Menthol Inhalant Product

Intervention Type DRUG

Menthol inhaler will be administered to determine the effects on vascular function.

Interventions

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E-cigarette

E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.

Intervention Type DRUG

Nicotine 0%

E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.

Intervention Type DRUG

Menthol Inhalant Product

Menthol inhaler will be administered to determine the effects on vascular function.

Intervention Type DRUG

Other Intervention Names

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Nicotine 5.4% Placebo Placebo

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hirofumi Tanaka, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Cardiovascular Aging Research Lab at UT Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31531991 (View on PubMed)

Other Identifiers

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2016-04-0115

Identifier Type: -

Identifier Source: org_study_id

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