Back to resultsE-Cigarettes and SNA
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
one time exposure to e-cig with nicotine
One time exposure to e-cigarette without nicotine
one time exposure to empty e-cigarette
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence focused on measuring nicotine, autonomic tone, 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 Type
Experimental
Experimental
Sham Comparator
Arm Label
nicotine
no nicotine
sham comparator
Arm Description
use of an e-cigarette filled with liquid with nicotine
Use of an e-cigarette filled with liquid without nicotine
Use of empty e-cigarette (sham control)
Outcomes
Primary Outcome Measures
Heart Rate variability
Heart rate variability is a measure of autonomic tone
Paraoxonase
plasma oxidative stress
Secondary Outcome Measures
muscle sympathetic nerve activity
Muscle sympathetic nerve activity (MSNA)
Full Information
NCT ID
NCT02724241
First Posted
March 17, 2016
Last Updated
December 3, 2021
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02724241
Brief Title
E-Cigarettes and SNA
Official Title
The Effects of Electronic Cigarettes on Sympathetic Nerve Activity and Oxidative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.
Detailed Description
Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine, autonomic tone, 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
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nicotine
Arm Type
Experimental
Arm Description
use of an e-cigarette filled with liquid with nicotine
Arm Title
no nicotine
Arm Type
Experimental
Arm Description
Use of an e-cigarette filled with liquid without nicotine
Arm Title
sham comparator
Arm Type
Sham Comparator
Arm Description
Use of empty e-cigarette (sham control)
Intervention Type
Other
Intervention Name(s)
one time exposure to e-cig with nicotine
Intervention Description
one time exposure to e-cigarette vapor with nicotine
Intervention Type
Other
Intervention Name(s)
One time exposure to e-cigarette without nicotine
Intervention Description
One time exposure to e-cig without nicotine
Intervention Type
Other
Intervention Name(s)
one time exposure to empty e-cigarette
Other Intervention Name(s)
sham control
Intervention Description
one time exposure to empty e-cigarette (sham control)
Primary Outcome Measure Information:
Title
Heart Rate variability
Description
Heart rate variability is a measure of autonomic tone
Time Frame
10 minutes after exposure
Title
Paraoxonase
Description
plasma oxidative stress
Time Frame
less than 1 hour after exposure
Secondary Outcome Measure Information:
Title
muscle sympathetic nerve activity
Description
Muscle sympathetic nerve activity (MSNA)
Time Frame
10 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
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E-Cigarettes and SNA
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