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NCT03072628 Clinical Trial

E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Nicotine Dependence Clinical Trial

Official title:
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03072628
Other study ID # 14-000743-AM-00008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2017
Est. completion date December 1, 2022

Study information
Verified date October 2023
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, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Description:

Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
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:
• e-cig with nicotine
use an e-cig with nicotine for 30 minutes
• e-cig without nicotine
use an e-cig without nicotine for 30 minutes
• nicotine inhaler
use a nicotine inhaler for 30 minutes
• sham control
use an empty e-cigarette for 30 minutes

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 Flow Mediated dilatation (FMD) FMD is a measure of endothelial function 10 minutes after exposure
Primary Heart rate variability (HRV) HRV is a measure of cardiac sympathetic tone 10 minutes after exposure
Secondary Paraoxonase (PON) PON is a measure of oxidative stress ~30 minutes after exposure
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