E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Nicotine Dependence

Treatments: Other: e-cig with nicotine; Other: nicotine inhaler; Other: sham control; Other: e-cig without nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT03072628

14-000743-AM-00008

Details and patient eligibility

About

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

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy

Exclusion criteria

• Cardiac disease
• Respiratory disease
• Diabetes mellitus

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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148 participants in 4 patient groups

Nicotine: use e-cig with nicotine

Experimental group

Description:

One time exposure to e-cig with nicotine

Treatment:

Other: e-cig with nicotine

no nicotine: use e-cig without nicotine

Experimental group

Description:

One time exposure to e-cig without nicotine

Treatment:

Other: e-cig without nicotine

Nicotine inhaler: use a nictoine inhaler

Experimental group

Description:

One time exposure to nicotine inhaler

Treatment:

Other: nicotine inhaler

Sham control

Sham Comparator group

Description:

Use an empty e-cigarette

Treatment:

Other: sham control