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OpenTrials
Completed

NCT Number: NCT04568395

Acute Effects of TCIG vs ECIG in PLWH

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

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Key information

Conditions

E Cigarette Use Behavior Chemically-Induced Disorders HIV I Infection Inflammation Mental Disorders Nicotine Use Disorder Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Qt Interval, Variation in Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder Vaping

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCIG

Other

Use a TCIG

ECIG

Other

Use an ECIG

Sham control

Other

Use a sham control (empty ECIG)

Primary outcomes

  1. Tpe

    Time frame: Change in Tpe 5 minutes after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  2. Tpe/QT

    Time frame: Change in Tpe/QT after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  3. Tpe/QTc

    Time frame: Change in Tpe/QTc after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  4. Total Cellular Reactive Oxygen Stress

    Time frame: within 4 hours of cigarette use

    total cellular oxidative stress measured by flow cytometry

Secondary outcomes

  1. QT

    Time frame: Change in QT after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  2. QTc

    Time frame: Change in QTc after cigarette use

    interval indicative of ventricular repolarization measured on ECG

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2020
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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