- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916341
Smoking and Ventricular Repolarization
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Holly R Middlekauff, MD
- Phone Number: 310-206-6672
- Email: hmiddlekauff@mednet.ucla.edu
Study Contact Backup
- Name: Karishma Lakhani, BS
- Phone Number: 310-825-3510
- Email: klakhani@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCaliforniaLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)
|
Use an EC with nicotine for up to 30 minutes
Use an EC without nicotine for up to 30 minutes
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)
|
Use an EC with nicotine for up to 30 minutes
Use an EC without nicotine for up to 30 minutes
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)
|
sham control
smoke a TC
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Death, Sudden
- Heart Arrest
- Death
- Death, Sudden, Cardiac
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 19-000452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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