E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

NCT ID: NCT03072628

Last Updated: 2023-10-04

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

2017-01-11

Study Completion Date

2022-12-01

Brief Summary

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Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Detailed Description

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Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.

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 e-cig with nicotine

One time exposure to e-cig with nicotine

Group Type EXPERIMENTAL

e-cig with nicotine

Intervention Type OTHER

use an e-cig with nicotine for 30 minutes

no nicotine: use e-cig without nicotine

One time exposure to e-cig without nicotine

Group Type EXPERIMENTAL

e-cig without nicotine

Intervention Type OTHER

use an e-cig without nicotine for 30 minutes

Nicotine inhaler: use a nictoine inhaler

One time exposure to nicotine inhaler

Group Type EXPERIMENTAL

nicotine inhaler

Intervention Type OTHER

use a nicotine inhaler for 30 minutes

Sham control

Use an empty e-cigarette

Group Type SHAM_COMPARATOR

sham control

Intervention Type OTHER

use an empty e-cigarette for 30 minutes

Interventions

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e-cig with nicotine

use an e-cig with nicotine for 30 minutes

Intervention Type OTHER

e-cig without nicotine

use an e-cig without nicotine for 30 minutes

Intervention Type OTHER

nicotine inhaler

use a nicotine inhaler for 30 minutes

Intervention Type OTHER

sham control

use an empty e-cigarette for 30 minutes

Intervention Type OTHER

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-AM-00008

Identifier Type: -

Identifier Source: org_study_id

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