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OpenTrials
Completed

NCT Number: NCT02724241

E-Cigarettes and SNA

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

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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 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.

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

one time exposure to e-cig with nicotine

Other

one time exposure to e-cigarette vapor with nicotine

One time exposure to e-cigarette without nicotine

Other

One time exposure to e-cig without nicotine

one time exposure to empty e-cigarette

Other

one time exposure to empty e-cigarette (sham control)

Other names: sham control

Primary outcomes

  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 outcomes

  1. muscle sympathetic nerve activity

    Time frame: 10 minutes after exposure

    Muscle sympathetic nerve activity (MSNA)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2016
Registry last updated
Dec 20, 2021

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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