NCT03823885

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 8, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

January 24, 2019

Last Update Submit

October 2, 2023

Conditions

E-cigarettes, Oxidative Stress, Inflammation

Outcome Measures

Primary Outcomes (1)

  • Cellular Reactive Oxygen Species, units = % fluorescence

    cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells

    within 4 hours of E-cig use

Secondary Outcomes (1)

  • CD 14+ Monocyte, units = % of total cells

    within 4 hours of e-cig use

Study Arms (2)

E-cig

EXPERIMENTAL

One time exposure to e-cig

Other: e-cigarette

sham

EXPERIMENTAL

One time exposure to empty e-cig

Other: empty (-cigarette sham control)

Interventions

e-cigaretteOTHER

use e-cig for 30 minutes

Also known as: e-cig
E-cig
empty (-cigarette sham control)OTHER

use empty e-cig (sham control)

Also known as: empty e-cig
sham

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

You may not qualify if:

  • Cardiac disease Respiratory disease Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Kelesidis T, Tran E, Arastoo S, Lakhani K, Heymans R, Gornbein J, Middlekauff HR. Elevated Cellular Oxidative Stress in Circulating Immune Cells in Otherwise Healthy Young People Who Use Electronic Cigarettes in a Cross-Sectional Single-Center Study: Implications for Future Cardiovascular Risk. J Am Heart Assoc. 2020 Sep 15;9(18):e016983. doi: 10.1161/JAHA.120.016983. Epub 2020 Sep 8.

    PMID: 32896211DERIVED

MeSH Terms

Conditions

VapingInflammation

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

SmokingBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Code
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover with 2 week washout
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 31, 2019

Study Start

February 8, 2019

Primary Completion

February 8, 2023

Study Completion

October 1, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)