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E-cigarettes and Blood Vessel Function

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ClinicalTrials.gov Identifier: NCT02740595
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Brief Summary:
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Other: one time exposure to e-cig with nicotine Other: one time exposure to e-cig without nicotine Other: one time exposure to empty e-cig Not Applicable

Detailed Description:
Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Study Start Date : August 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Nicotine
Use an e-cig filled with liquid with nicotine
Other: one time exposure to e-cig with nicotine
one time exposure to e-cig vapor with nicotine

Experimental: no nicotine
Use an e-cig filled with liquid without nicotine
Other: one time exposure to e-cig without nicotine
one time exposure to e-cig without nicotine

Sham Comparator: sham comparator
Use an empty e-cigarette (sham control)
Other: one time exposure to empty e-cig
one time exposure to empty e-cig (sham control
Other Name: sham control




Primary Outcome Measures :
  1. Flow mediated dilatation (FMD) [ Time Frame: 10 minutes after exposure ]
    FMD is a measure of endothelial function

  2. Paraoxonse [ Time Frame: less than 1 hour after exposure ]
    plasma oxidative stress



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus

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): NCT02740595


Contacts
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Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Kacey Peters, BS 310-825-3510 kpeters@mednet.ucla.edu

Locations
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United States, California
UCaliforniaLA Recruiting
Los Angeles, California, United States, 90095
Contact: Holly R Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
Principal Investigator: Holly R Middlekauff, MD         
Sponsors and Collaborators
University of California, Los Angeles

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Responsible Party: Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02740595     History of Changes
Other Study ID Numbers: 14-000743
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Holly R Middlekauff, University of California, Los Angeles:
nicotine
endothelial function
oxidative stress
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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