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NCT02724241 Clinical Trial

E-Cigarettes and SNA

Nicotine Dependence Clinical Trial

Official title:
The Effects of Electronic Cigarettes on Sympathetic Nerve Activity and Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02724241
Other study ID # 14-000731
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date December 2021

Study information
Verified date December 2021
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria: Healthy Exclusion Criteria: - Cardiac disease - Respiratory disease - Diabetes mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• one time exposure to e-cig with nicotine
one time exposure to e-cigarette vapor with nicotine
• One time exposure to e-cigarette without nicotine
One time exposure to e-cig without nicotine
• one time exposure to empty e-cigarette
one time exposure to empty e-cigarette (sham control)

Locations
Country Name City State
United States UCaliforniaLA Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart Rate variability Heart rate variability is a measure of autonomic tone 10 minutes after exposure
Primary Paraoxonase plasma oxidative stress less than 1 hour after exposure
Secondary muscle sympathetic nerve activity Muscle sympathetic nerve activity (MSNA) 10 minutes after exposure
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