Vascular Effects of a Single Bout of Electronic Cigarette Use

October 9, 2018 updated by: University of Texas at Austin
Investigating the acute effects of a single use E-Cigarette upon vascular health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Cardiovascular Aging Research Lab at UT Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: E-Cigarette 5.4% NBV
Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.
Drug: E-cigarette
E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.
Other Names:
  • Nicotine 5.4%
Placebo Comparator: E-Cigarette 0% NBV
Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.
Drug: Nicotine 0%
E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.
Other Names:
  • Placebo
Placebo Comparator: 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.
Drug: Menthol Inhalant Product
Menthol inhaler will be administered to determine the effects on vascular function.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Hirofumi Tanaka, Phd, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-04-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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