NCT02740595

Brief Summary

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

7.3 years

First QC Date

April 12, 2016

Last Update Submit

October 2, 2023

Conditions

Nicotine Dependence

Keywords

nicotineendothelial functionoxidative stress

Outcome Measures

Primary Outcomes (2)

  • Flow mediated dilatation (FMD)

    FMD is a measure of endothelial function

    10 minutes after exposure

  • Paraoxonse

    plasma oxidative stress

    less than 1 hour after exposure

Study Arms (3)

Nicotine

EXPERIMENTAL

Use an e-cig filled with liquid with nicotine

Other: one time exposure to e-cig with nicotine

no nicotine

EXPERIMENTAL

Use an e-cig filled with liquid without nicotine

Other: one time exposure to e-cig without nicotine

sham comparator

SHAM COMPARATOR

Use an empty e-cigarette (sham control)

Other: one time exposure to empty e-cig

Interventions

one time exposure to e-cig with nicotineOTHER

one time exposure to e-cig vapor with nicotine

Nicotine
one time exposure to e-cig without nicotineOTHER

one time exposure to e-cig without nicotine

no nicotine
one time exposure to empty e-cigOTHER

one time exposure to empty e-cig (sham control

Also known as: sham control
sham comparator

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

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

April 12, 2016

First Posted

April 15, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)