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OpenTrials
Completed

NCT Number: NCT03072628

E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Completed

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCaliforniaLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus

Treatment and study plan

e-cig with nicotine

Other

use an e-cig with nicotine for 30 minutes

e-cig without nicotine

Other

use an e-cig without nicotine for 30 minutes

nicotine inhaler

Other

use a nicotine inhaler for 30 minutes

Sham control

Other

use an empty e-cigarette for 30 minutes

Primary outcomes

  1. Flow Mediated dilatation (FMD)

    Time frame: 10 minutes after exposure

    FMD is a measure of endothelial function

  2. Heart rate variability (HRV)

    Time frame: 10 minutes after exposure

    HRV is a measure of cardiac sympathetic tone

Secondary outcomes

  1. Paraoxonase (PON)

    Time frame: ~30 minutes after exposure

    PON is a measure of oxidative stress

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2017
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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