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NCT02740595 Clinical Trial

E-cigarettes 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 NCT02740595
Other study ID # 14-000743
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
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, and sham control, on endothelial function 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 undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

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:
• one time exposure to e-cig with nicotine
one time exposure to e-cig vapor with nicotine
• one time exposure to e-cig without nicotine
one time exposure to e-cig without nicotine
• one time exposure to empty e-cig
one time exposure to empty e-cig (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 Flow mediated dilatation (FMD) FMD is a measure of endothelial function 10 minutes after exposure
Primary Paraoxonse plasma oxidative stress less than 1 hour after exposure
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