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Vascular Effects of a Single Bout of Electronic Cigarette Use

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT03209661
Collaborator
(none)
16
Enrollment
1
Location
3
Arms
16.1
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Participant)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
Vascular Effects of a Single Bout of Electronic Cigarette Use
Actual Study Start Date :
Apr 28, 2017
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 31, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiovascular Aging Research Lab at UT Austin Austin Texas United States 78712

    Sponsors and Collaborators

    • University of Texas at Austin

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Texas at Austin
    ClinicalTrials.gov Identifier:
    NCT03209661
    Other Study ID Numbers:
    • 2016-04-0115
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Oct 11, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Texas at Austin
    vascular function
    Additional relevant MeSH terms:
    Menthol
    Nicotine

    Study Results

    No Results Posted as of Oct 11, 2018