E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

October 2, 2023 updated by: Holly R Middlekauff, University of California, Los Angeles

The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCaliforniaLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine: use e-cig with nicotine
One time exposure to e-cig with nicotine
Other: e-cig with nicotine
use an e-cig with nicotine for 30 minutes
Experimental: no nicotine: use e-cig without nicotine
One time exposure to e-cig without nicotine
Other: e-cig without nicotine
use an e-cig without nicotine for 30 minutes
Experimental: Nicotine inhaler: use a nictoine inhaler
One time exposure to nicotine inhaler
Other: nicotine inhaler
use a nicotine inhaler for 30 minutes
Sham Comparator: Sham control
Use an empty e-cigarette
Other: sham control
use an empty e-cigarette for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated dilatation (FMD)
Time Frame: 10 minutes after exposure
FMD is a measure of endothelial function
10 minutes after exposure
Heart rate variability (HRV)
Time Frame: 10 minutes after exposure
HRV is a measure of cardiac sympathetic tone
10 minutes after exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paraoxonase (PON)
Time Frame: ~30 minutes after exposure
PON is a measure of oxidative stress
~30 minutes after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2017

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000743-AM-00008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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