Smoking and Ventricular Repolarization

October 2, 2023 updated by: Holly R Middlekauff, University of California, Los Angeles
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).

Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.

Study Type

Interventional

Enrollment (Actual)

110

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

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

Yes

Description

Inclusion Criteria:

  • Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)

Exclusion Criteria:

  • Cardiac disease, respiratory disease, diabetes

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-user
Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
Other: EC with nicotine
Use an EC with nicotine for up to 30 minutes
Other: EC without nicotine
Use an EC without nicotine for up to 30 minutes
Other: control
sham control
Experimental: Chronic EC user
Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
Other: EC with nicotine
Use an EC with nicotine for up to 30 minutes
Other: EC without nicotine
Use an EC without nicotine for up to 30 minutes
Other: control
sham control
Experimental: Chronic TC smoker
Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control)
Other: control
sham control
Other: TC with nicotine (own brand)
smoke a TC
Other: research TC with very low level nicotine
smoke a research TC with very low level nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tpe
Time Frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
Change in Tpe 5 minutes before and 5 minutes after cigarette use
Tpe/QT
Time Frame: Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
ratio of intervals indicative of ventricular repolarization measured on ECG
Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
Tpe/QTc
Time Frame: Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
ratio of intervals indicative of ventricular repolarization measured on ECG
Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT
Time Frame: Change in QT 5 minutes before and 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
Change in QT 5 minutes before and 5 minutes after cigarette use
QTc
Time Frame: Change in QTc 5 minutes before and 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
Change in QTc 5 minutes before and 5 minutes 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, 2019

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 16, 2019

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-000452

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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