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E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Nicotine Dependence

Treatments

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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