Acute Effects of TCIG vs ECIG in PLWH

NCT04568395 | Completed

• 1 other identifier: 20-001179
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Tpe

  interval indicative of ventricular repolarization measured on ECG

  Change in Tpe 5 minutes after cigarette use

• Tpe/QT

  interval indicative of ventricular repolarization measured on ECG

  Change in Tpe/QT after cigarette use

• Tpe/QTc

  interval indicative of ventricular repolarization measured on ECG

  Change in Tpe/QTc after cigarette use

• Total Cellular Reactive Oxygen Stress

  total cellular oxidative stress measured by flow cytometry

  within 4 hours of cigarette use

Secondary Outcomes (2)

• QT

  Change in QT after cigarette use

• QTc

  Change in QTc after cigarette use

Study Arms (1)

PLWH smoker

EXPERIMENTAL

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

Other: TCIG; Other: ECIG; Other: sham control

Interventions

TCIG OTHER

Use a TCIG

PLWH smoker

ECIG OTHER

Use an ECIG

PLWH smoker

sham control OTHER

Use a sham control (empty ECIG)

PLWH smoker

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (2)

UCLA

Los Angeles, California, 890095, United States

Location

UCaliforniaLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Vaping; Smoking; Tobacco Smoking; Tobacco Use Disorder; Inflammation

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: single (outcomes assessor) code
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover with 1 week washout

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: October 1, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)