ECigs, Inflammation and Oxidative Stress

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

E-Cigarettes and Monocytes

Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.

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 Contact

Study Locations

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

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-cig
One time exposure to e-cig
Other: e-cigarette
use e-cig for 30 minutes
Other Names:
  • e-cig
Experimental: sham
One time exposure to empty e-cig
Other: empty (-cigarette sham control)
use empty e-cig (sham control)
Other Names:
  • empty e-cig

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular Reactive Oxygen Species, units = % fluorescence
Time Frame: within 4 hours of E-cig use
cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
within 4 hours of E-cig use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD 14+ Monocyte, units = % of total cells
Time Frame: within 4 hours of e-cig use
CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye
within 4 hours of e-cig use

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Collaborators

Tobacco Related Disease Research Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 8, 2019

Primary Completion (Actual)

February 8, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 31, 2019

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18001147

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

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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