Acute Effects of TCIG vs ECIG in PLWH

Inflammation Clinical Trial

Official title:

Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568395
• Other study ID #: 20-001179
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• E Cigarette Use
• HIV I Infection
• Inflammation
• Nicotine Use Disorder
• Oxidative Stress
• Qt Interval, Variation in
• Smoking
• Tobacco Smoking
• Tobacco Use Disorder
• Vaping

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