E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
1 other identifier
interventional
148
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2017
CompletedFirst Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 4, 2023
October 1, 2023
5.9 years
March 2, 2017
October 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Flow Mediated dilatation (FMD)
FMD is a measure of endothelial function
10 minutes after exposure
Heart rate variability (HRV)
HRV is a measure of cardiac sympathetic tone
10 minutes after exposure
Secondary Outcomes (1)
Paraoxonase (PON)
~30 minutes after exposure
Study Arms (4)
Nicotine: use e-cig with nicotine
EXPERIMENTALOne time exposure to e-cig with nicotine
no nicotine: use e-cig without nicotine
EXPERIMENTALOne time exposure to e-cig without nicotine
Nicotine inhaler: use a nictoine inhaler
EXPERIMENTALOne time exposure to nicotine inhaler
Sham control
SHAM COMPARATORUse an empty e-cigarette
Interventions
use an e-cig without nicotine for 30 minutes
Eligibility Criteria
You may qualify if:
- Healthy
You may not qualify if:
- Cardiac disease
- Respiratory disease
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCaliforniaLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 7, 2017
Study Start
January 11, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
October 4, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share