Back to resultsE-cigarettes, Nicotine Inhaler, and Blood Vessel Function
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-cig with nicotine
e-cig without nicotine
nicotine inhaler
sham control
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence focused on measuring nicotine, sympathetic nerve activity, oxidative stress
Eligibility Criteria
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Cardiac disease
- Respiratory disease
- Diabetes mellitus
Sites / Locations
- UCaliforniaLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Nicotine: use e-cig with nicotine
no nicotine: use e-cig without nicotine
Nicotine inhaler: use a nictoine inhaler
Sham control
Arm Description
One time exposure to e-cig with nicotine
One time exposure to e-cig without nicotine
One time exposure to nicotine inhaler
Use an empty e-cigarette
Outcomes
Primary Outcome Measures
Flow Mediated dilatation (FMD)
FMD is a measure of endothelial function
Heart rate variability (HRV)
HRV is a measure of cardiac sympathetic tone
Secondary Outcome Measures
Paraoxonase (PON)
PON is a measure of oxidative stress
Full Information
NCT ID
NCT03072628
First Posted
March 2, 2017
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03072628
Brief Title
E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
Official Title
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine, sympathetic nerve activity, oxidative stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine: use e-cig with nicotine
Arm Type
Experimental
Arm Description
One time exposure to e-cig with nicotine
Arm Title
no nicotine: use e-cig without nicotine
Arm Type
Experimental
Arm Description
One time exposure to e-cig without nicotine
Arm Title
Nicotine inhaler: use a nictoine inhaler
Arm Type
Experimental
Arm Description
One time exposure to nicotine inhaler
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Use an empty e-cigarette
Intervention Type
Other
Intervention Name(s)
e-cig with nicotine
Intervention Description
use an e-cig with nicotine for 30 minutes
Intervention Type
Other
Intervention Name(s)
e-cig without nicotine
Intervention Description
use an e-cig without nicotine for 30 minutes
Intervention Type
Other
Intervention Name(s)
nicotine inhaler
Intervention Description
use a nicotine inhaler for 30 minutes
Intervention Type
Other
Intervention Name(s)
sham control
Intervention Description
use an empty e-cigarette for 30 minutes
Primary Outcome Measure Information:
Title
Flow Mediated dilatation (FMD)
Description
FMD is a measure of endothelial function
Time Frame
10 minutes after exposure
Title
Heart rate variability (HRV)
Description
HRV is a measure of cardiac sympathetic tone
Time Frame
10 minutes after exposure
Secondary Outcome Measure Information:
Title
Paraoxonase (PON)
Description
PON is a measure of oxidative stress
Time Frame
~30 minutes after exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Exclusion Criteria:
Cardiac disease
Respiratory disease
Diabetes mellitus
Facility Information:
Facility Name
UCaliforniaLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
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