Smoking and Ventricular Repolarization

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03916341
• Collaborator: Tobacco Related Disease Research Program (Other)
• Enrollment: 145
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 54.3
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

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 Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tpe [Change in Tpe 5 minutes before and 5 minutes after cigarette use]

   interval indicative of ventricular repolarization measured on ECG

2. Tpe/QT [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 [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 [Change in QT 5 minutes before and 5 minutes after cigarette use]

   interval indicative of ventricular repolarization measured on ECG

2. QTc [Change in QTc 5 minutes before and 5 minutes after cigarette use]

   interval indicative of ventricular repolarization measured on ECG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCaliforniaLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles
• Tobacco Related Disease Research Program

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holly R Middlekauff, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03916341
• Other Study ID Numbers: 19-000452
• First Posted: Apr 16, 2019
• Last Update Posted: Dec 7, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Holly R Middlekauff, Principal Investigator, University of California, Los Angeles: e-cigarettes; tobacco cigarettes; nicotine; ventricular repolarization
• Additional relevant MeSH terms: Death, Sudden, Cardiac; Death; Nicotine

Study Results

No Results Posted as of Dec 7, 2021