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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04568395
Other study ID # 20-001179
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date May 8, 2023

Study information

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

Clinical Trial Summary

Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.


Description:

On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 8, 2023
Est. primary completion date May 8, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria: Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500 Exclusion Criteria: Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection

Study Design


Intervention

Other:
TCIG
Use a TCIG
ECIG
Use an ECIG
sham control
Use a sham control (empty ECIG)

Locations

Country Name City State
United States UCaliforniaLA Los Angeles California
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 Tpe interval indicative of ventricular repolarization measured on ECG Change in Tpe 5 minutes after cigarette use
Primary Tpe/QT interval indicative of ventricular repolarization measured on ECG Change in Tpe/QT after cigarette use
Primary Tpe/QTc interval indicative of ventricular repolarization measured on ECG Change in Tpe/QTc after cigarette use
Primary Total Cellular Reactive Oxygen Stress total cellular oxidative stress measured by flow cytometry within 4 hours of cigarette use
Secondary QT interval indicative of ventricular repolarization measured on ECG Change in QT after cigarette use
Secondary QTc interval indicative of ventricular repolarization measured on ECG Change in QTc after cigarette use
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