Back to resultsE-cigarettes and Blood Vessel Function
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-cig without nicotine
one time exposure to empty e-cig
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence focused on measuring nicotine, endothelial function, 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 an e-cig filled with liquid with nicotine
Use an e-cig filled with liquid without nicotine
Use an empty e-cigarette (sham control)
Outcomes
Primary Outcome Measures
Flow mediated dilatation (FMD)
FMD is a measure of endothelial function
Paraoxonse
plasma oxidative stress
Secondary Outcome Measures
Full Information
NCT ID
NCT02740595
First Posted
April 12, 2016
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02740595
Brief Title
E-cigarettes 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
August 2015 (undefined)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function 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 undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, 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, endothelial function, 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
Arm Type
Experimental
Arm Description
Use an e-cig filled with liquid with nicotine
Arm Title
no nicotine
Arm Type
Experimental
Arm Description
Use an e-cig filled with liquid without nicotine
Arm Title
sham comparator
Arm Type
Sham Comparator
Arm Description
Use an 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-cig vapor with nicotine
Intervention Type
Other
Intervention Name(s)
one time exposure to e-cig without nicotine
Intervention Description
one time exposure to e-cig without nicotine
Intervention Type
Other
Intervention Name(s)
one time exposure to empty e-cig
Other Intervention Name(s)
sham control
Intervention Description
one time exposure to empty e-cig (sham control
Primary Outcome Measure Information:
Title
Flow mediated dilatation (FMD)
Description
FMD is a measure of endothelial function
Time Frame
10 minutes after exposure
Title
Paraoxonse
Description
plasma oxidative stress
Time Frame
less than 1 hour 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 Blood Vessel Function
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