E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

University of California, Los Angeles148 enrolled

Overview

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

148

Conditions

Nicotine Dependence

Interventions

e-cig with nicotineOTHER

use an e-cig with nicotine for 30 minutes

e-cig without nicotineOTHER

use an e-cig without nicotine for 30 minutes

nicotine inhalerOTHER

use a nicotine inhaler for 30 minutes

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Exclusion Criteria: * Cardiac disease * Respiratory disease * Diabetes mellitus

Locations (1)

UCaliforniaLA

Los Angeles, California, United States

Outcomes

Primary Outcomes

Flow Mediated dilatation (FMD)

FMD is a measure of endothelial function

Time frame: 10 minutes after exposure

Heart rate variability (HRV)

HRV is a measure of cardiac sympathetic tone

Time frame: 10 minutes after exposure

Secondary Outcomes

Paraoxonase (PON)

PON is a measure of oxidative stress

Time frame: ~30 minutes after exposure

Data from ClinicalTrials.gov

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