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E-Cigarettes and SNA

NCT ID: NCT02724241

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nicotine Dependence

Keywords

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nicotine autonomic tone oxidative stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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nicotine

use of an e-cigarette filled with liquid with nicotine

Group Type EXPERIMENTAL

one time exposure to e-cig with nicotine

Intervention Type OTHER

one time exposure to e-cigarette vapor with nicotine

no nicotine

Use of an e-cigarette filled with liquid without nicotine

Group Type EXPERIMENTAL

One time exposure to e-cigarette without nicotine

Intervention Type OTHER

One time exposure to e-cig without nicotine

sham comparator

Use of empty e-cigarette (sham control)

Group Type SHAM_COMPARATOR

one time exposure to empty e-cigarette

Intervention Type OTHER

one time exposure to empty e-cigarette (sham control)

Interventions

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one time exposure to e-cig with nicotine

one time exposure to e-cigarette vapor with nicotine

Intervention Type OTHER

One time exposure to e-cigarette without nicotine

One time exposure to e-cig without nicotine

Intervention Type OTHER

one time exposure to empty e-cigarette

one time exposure to empty e-cigarette (sham control)

Intervention Type OTHER

Other Intervention Names

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sham control

Eligibility Criteria

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Inclusion Criteria

Healthy

Exclusion Criteria

* Cardiac disease
* Respiratory disease
* Diabetes mellitus
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Holly R Middlekauff

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCaliforniaLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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14-000731

Identifier Type: -

Identifier Source: org_study_id