E-cigarettes and Blood Vessel Function

NCT ID: NCT02740595

Last Updated: 2023-10-05

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

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2022-12-01

Brief Summary

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Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function 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 undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

Conditions

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Nicotine Dependence

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 an e-cig filled with liquid with nicotine

Group Type EXPERIMENTAL

one time exposure to e-cig with nicotine

Intervention Type OTHER

one time exposure to e-cig vapor with nicotine

no nicotine

Use an e-cig filled with liquid without nicotine

Group Type EXPERIMENTAL

one time exposure to e-cig without nicotine

Intervention Type OTHER

one time exposure to e-cig without nicotine

sham comparator

Use an empty e-cigarette (sham control)

Group Type SHAM_COMPARATOR

one time exposure to empty e-cig

Intervention Type OTHER

one time exposure to empty e-cig (sham control

Interventions

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one time exposure to e-cig with nicotine

one time exposure to e-cig vapor with nicotine

Intervention Type OTHER

one time exposure to e-cig without nicotine

one time exposure to e-cig without nicotine

Intervention Type OTHER

one time exposure to empty e-cig

one time exposure to empty e-cig (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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14-000743

Identifier Type: -

Identifier Source: org_study_id

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