ECigs, Inflammation and Oxidative Stress

E-cigarettes, Oxidative Stress, Inflammation Clinical Trial

Official title:

E-Cigarettes and Monocytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823885
• Other study ID #: 18001147
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 1, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Cardiac disease Respiratory disease Diabetes

Related Conditions & MeSH terms

• E-cigarettes, Oxidative Stress, Inflammation
• Inflammation

Intervention

Other:
• e-cigarette
use e-cig for 30 minutes
• empty (-cigarette sham control)
use empty e-cig (sham control)

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CD 14+ Monocyte, units = % of total cells	CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye	within 4 hours of e-cig use