Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

E-Cigarettes and SNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724241
Recruitment Status : Recruiting
First Posted : March 31, 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 sympathetic nerve activity 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-cigarette without nicotine Other: one time exposure to empty e-cigarette Not Applicable

Detailed Description:
Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.

Layout table for study information
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 Sympathetic Nerve Activity and Oxidative Stress
Study Start Date : April 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 of an e-cigarette filled with liquid with nicotine
Other: one time exposure to e-cig with nicotine
one time exposure to e-cigarette vapor with nicotine

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

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




Primary Outcome Measures :
  1. Heart Rate variability [ Time Frame: 10 minutes after exposure ]
    Heart rate variability is a measure of autonomic tone

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


Secondary Outcome Measures :
  1. muscle sympathetic nerve activity [ Time Frame: 10 minutes after exposure ]
    Muscle sympathetic nerve activity (MSNA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT02724241


Contacts
Layout table for location contacts
Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Kacey Peters, MS 310-825-2530 kpeters@mednet.ucla.edu

Locations
Layout table for location information
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

Layout table for additonal information
Responsible Party: Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02724241    
Other Study ID Numbers: 14-000731
First Posted: March 31, 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
autonomic tone
oxidative stress
Additional relevant MeSH terms:
Layout table for MeSH terms
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