Nicotine Dependence
Conditions
Keywords
nicotine, sympathetic nerve activity, oxidative stress
Brief summary
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity
Detailed description
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.
Interventions
OTHERe-cig with nicotine
use an e-cig with nicotine for 30 minutes
OTHERe-cig without nicotine
use an e-cig without nicotine for 30 minutes
OTHERnicotine inhaler
use a nicotine inhaler for 30 minutes
OTHERsham control
use an empty e-cigarette for 30 minutes
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy
Exclusion criteria
* Cardiac disease * Respiratory disease * Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated dilatation (FMD) | 10 minutes after exposure | FMD is a measure of endothelial function |
| Heart rate variability (HRV) | 10 minutes after exposure | HRV is a measure of cardiac sympathetic tone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paraoxonase (PON) | ~30 minutes after exposure | PON is a measure of oxidative stress |
Countries
United States
Outcome results
None listed