NCT02724241

Brief Summary

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

April 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

6.7 years

First QC Date

March 17, 2016

Last Update Submit

December 3, 2021

Conditions

Nicotine Dependence

Keywords

nicotineautonomic toneoxidative stress

Outcome Measures

Primary Outcomes (2)

  • Heart Rate variability

    Heart rate variability is a measure of autonomic tone

    10 minutes after exposure

  • Paraoxonase

    plasma oxidative stress

    less than 1 hour after exposure

Secondary Outcomes (1)

  • muscle sympathetic nerve activity

    10 minutes after exposure

Study Arms (3)

nicotine

EXPERIMENTAL

use of an e-cigarette filled with liquid with nicotine

Other: one time exposure to e-cig with nicotine

no nicotine

EXPERIMENTAL

Use of an e-cigarette filled with liquid without nicotine

Other: One time exposure to e-cigarette without nicotine

sham comparator

SHAM COMPARATOR

Use of empty e-cigarette (sham control)

Other: one time exposure to empty e-cigarette

Interventions

one time exposure to e-cig with nicotineOTHER

one time exposure to e-cigarette vapor with nicotine

nicotine
One time exposure to e-cigarette without nicotineOTHER

One time exposure to e-cig without nicotine

no nicotine
one time exposure to empty e-cigaretteOTHER

one time exposure to empty e-cigarette (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

March 17, 2016

First Posted

March 31, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)