Smoking and Ventricular Repolarization

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Sudden Cardiac Death; Prolonged QTc Interval

Treatments: Other: research TC with very low level nicotine; Other: EC without nicotine; Other: TC with nicotine (own brand); Other: EC with nicotine; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT03916341

19-000452

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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110 participants in 3 patient groups

Non-user

Experimental group

Description:

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)

Treatment:

Other: control

Other: EC with nicotine

Other: EC without nicotine

Chronic EC user

Experimental group

Description:

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)

Treatment:

Other: control

Other: EC with nicotine

Other: EC without nicotine

Chronic TC smoker

Experimental group

Description:

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)

Treatment:

Other: control

Other: TC with nicotine (own brand)

Other: research TC with very low level nicotine