Acute Effects of TCIG vs ECIG in PLWH

October 2, 2023 updated by: Holly R Middlekauff, University of California, Los Angeles

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCaliforniaLA
      • Los Angeles, California, United States, 890095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLWH smoker
PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control
Other: TCIG
Use a TCIG
Other: ECIG
Use an ECIG
Other: sham control
Use a sham control (empty ECIG)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT
Time Frame: Change in QT after cigarette use
interval indicative of ventricular repolarization measured on ECG
Change in QT after cigarette use
QTc
Time Frame: Change in QTc after cigarette use
interval indicative of ventricular repolarization measured on ECG
Change in QTc after cigarette use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Tobacco Related Disease Research Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-001179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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