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Acute Effects of TCIG vs ECIG in PLWH

Primary Purpose

E Cigarette Use, Vaping, Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TCIG
ECIG
sham control
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for E Cigarette Use

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • UCaliforniaLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLWH smoker

Arm Description

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

Outcomes

Primary Outcome Measures

Tpe
interval indicative of ventricular repolarization measured on ECG
Tpe/QT
interval indicative of ventricular repolarization measured on ECG
Tpe/QTc
interval indicative of ventricular repolarization measured on ECG
Total Cellular Reactive Oxygen Stress
total cellular oxidative stress measured by flow cytometry

Secondary Outcome Measures

QT
interval indicative of ventricular repolarization measured on ECG
QTc
interval indicative of ventricular repolarization measured on ECG

Full Information

First Posted
September 18, 2020
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT04568395
Brief Title
Acute Effects of TCIG vs ECIG in PLWH
Official Title
Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
E Cigarette Use, Vaping, Smoking, Tobacco Smoking, Nicotine Use Disorder, Qt Interval, Variation in, HIV I Infection, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Crossover with 1 week washout
Masking
None (Open Label)
Masking Description
single (outcomes assessor) code
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLWH smoker
Arm Type
Experimental
Arm Description
PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control
Intervention Type
Other
Intervention Name(s)
TCIG
Intervention Description
Use a TCIG
Intervention Type
Other
Intervention Name(s)
ECIG
Intervention Description
Use an ECIG
Intervention Type
Other
Intervention Name(s)
sham control
Intervention Description
Use a sham control (empty ECIG)
Primary Outcome Measure Information:
Title
Tpe
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe 5 minutes after cigarette use
Title
Tpe/QT
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe/QT after cigarette use
Title
Tpe/QTc
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe/QTc after cigarette use
Title
Total Cellular Reactive Oxygen Stress
Description
total cellular oxidative stress measured by flow cytometry
Time Frame
within 4 hours of cigarette use
Secondary Outcome Measure Information:
Title
QT
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in QT after cigarette use
Title
QTc
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in QTc after cigarette use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
890095
Country
United States
Facility Name
UCaliforniaLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Effects of TCIG vs ECIG in PLWH

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