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Smoking and Ventricular Repolarization

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ClinicalTrials.gov Identifier: NCT03916341
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Brief Summary:
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Prolonged QTc Interval Other: EC with nicotine Other: EC without nicotine Other: control Other: TC with nicotine (own brand) Other: research TC with very low level nicotine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover with 4 week washout
Masking: Single (Outcomes Assessor)
Masking Description: Single (outcomes assessor) code
Primary Purpose: Basic Science
Official Title: Smoking and Ventricular Repolarization
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : April 10, 2024

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




Primary Outcome Measures :
  1. Tpe [ Time Frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  2. 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

  3. 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


Secondary Outcome Measures :
  1. QT [ Time Frame: Change in QT 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  2. QTc [ Time Frame: Change in QTc 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916341


Contacts
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Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Karishma Lakhani, BS 310-825-3510 klakhani@mednet.ucla.edu

Locations
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United States, California
UCaliforniaLA Recruiting
Los Angeles, California, United States, 90095
Contact: Holly R Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
Contact: Karishma Lakhani, BS    310-825-3510    klakhani@mednet.ucla.edu   
Principal Investigator: Holly R Middlekauff, MD         
Sponsors and Collaborators
University of California, Los Angeles
Tobacco Related Disease Research Program

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Responsible Party: Holly R Middlekauff, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03916341     History of Changes
Other Study ID Numbers: 19-000452
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holly R Middlekauff, University of California, Los Angeles:
e-cigarettes
tobacco cigarettes
nicotine
ventricular repolarization
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action