Acute Effects of TCIG vs ECIG in PLWH

Not Applicable

Completed

• Conditions: Oxidative Stress; Nicotine Use Disorder; HIV I Infection; Inflammation; Smoking; Vaping; Tobacco Smoking; Qt Interval, Variation in; E Cigarette Use
• Interventions: Other: TCIG; Other: ECIG; Other: sham control

• Registration Number: NCT04568395
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2020-10-01
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PLWH smoker	TCIG	PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control
PLWH smoker	ECIG	PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control
PLWH smoker	sham control	PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control

Primary Outcome Measures

Name	Time	Method
Tpe/QTc	Change in Tpe/QTc after cigarette use	interval indicative of ventricular repolarization measured on ECG
Tpe	Change in Tpe 5 minutes after cigarette use	interval indicative of ventricular repolarization measured on ECG
Total Cellular Reactive Oxygen Stress	within 4 hours of cigarette use	total cellular oxidative stress measured by flow cytometry
Tpe/QT	Change in Tpe/QT after cigarette use	interval indicative of ventricular repolarization measured on ECG

Secondary Outcome Measures

Name	Time	Method
QT	Change in QT after cigarette use	interval indicative of ventricular repolarization measured on ECG
QTc	Change in QTc after cigarette use	interval indicative of ventricular repolarization measured on ECG

Trial Locations

Locations (2)

UCLA; 🇺🇸 Los Angeles, California, United States

UCaliforniaLA; 🇺🇸 Los Angeles, California, United States