CClinicalTrials.gg
CompletedNCT03072628Updated Oct 4, 2023

E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

An interventional study of e-cig with nicotine and e-cig without nicotine in Nicotine Dependence, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Nicotine Dependence

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Keywords

  • nicotine
  • sympathetic nerve activity
  • oxidative stress
03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 148 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy

Exclusion criteria

Exclusion Criteria:

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    Nicotine: use e-cig with nicotine

    One time exposure to e-cig with nicotine

    Other: e-cig with nicotine

  • Experimental
    no nicotine: use e-cig without nicotine

    One time exposure to e-cig without nicotine

    Other: e-cig without nicotine

  • Experimental
    Nicotine inhaler: use a nictoine inhaler

    One time exposure to nicotine inhaler

    Other: nicotine inhaler

  • Sham comparator
    Sham control

    Use an empty e-cigarette

    Other: sham control

Interventions

  • Othere-cig with nicotine

    use an e-cig with nicotine for 30 minutes

  • Othere-cig without nicotine

    use an e-cig without nicotine for 30 minutes

  • Othernicotine inhaler

    use a nicotine inhaler for 30 minutes

  • Othersham control

    use an empty e-cigarette for 30 minutes

06

What researchers measure

Primary outcomes

  1. Flow Mediated dilatation (FMD)

    FMD is a measure of endothelial function

    Time frame: 10 minutes after exposure

  2. Heart rate variability (HRV)

    HRV is a measure of cardiac sympathetic tone

    Time frame: 10 minutes after exposure

Secondary outcomes

  1. Paraoxonase (PON)

    PON is a measure of oxidative stress

    Time frame: ~30 minutes after exposure

07

Study locations

1 site
  • UCaliforniaLA
    Los Angeles, California 90095, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03072628
Lead sponsor
University of California, Los Angeles
Responsible party
Holly R Middlekauff (Professor of Medicine, University of California, Los Angeles) — Principal investigator
First posted
Mar 7, 2017
Start date
Jan 11, 2017
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022
Last update
Oct 4, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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