E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Other: e-cig with nicotine; Other: nicotine inhaler; Other: e-cig without nicotine; Other: sham control

• Registration Number: NCT03072628
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-11
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-07
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Healthy

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Exclusion Criteria

• Cardiac disease
• Respiratory disease
• Diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine: use e-cig with nicotine	e-cig with nicotine	One time exposure to e-cig with nicotine
Nicotine inhaler: use a nictoine inhaler	nicotine inhaler	One time exposure to nicotine inhaler
no nicotine: use e-cig without nicotine	e-cig without nicotine	One time exposure to e-cig without nicotine
Sham control	sham control	Use an empty e-cigarette

Primary Outcome Measures

Name	Time	Method
Flow Mediated dilatation (FMD)	10 minutes after exposure	FMD is a measure of endothelial function
Heart rate variability (HRV)	10 minutes after exposure	HRV is a measure of cardiac sympathetic tone

Secondary Outcome Measures

Name	Time	Method
Paraoxonase (PON)	~30 minutes after exposure	PON is a measure of oxidative stress

Trial Locations

Locations (1)

UCaliforniaLA; 🇺🇸 Los Angeles, California, United States