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Vascular Effects of a Single Bout of Electronic Cigarette Use

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ClinicalTrials.gov Identifier: NCT03209661
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

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

Condition or disease Intervention/treatment Phase
Arterial Stiffness Drug: E-cigarette Drug: Nicotine 0% Drug: Menthol Inhalant Product 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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : April 28, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes
Drug Information available for: Menthol

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 Name: 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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209661


Locations
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United States, Texas
Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Hirofumi Tanaka, Phd University of Texas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03209661    
Other Study ID Numbers: 2016-04-0115
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Menthol
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents