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Completed

NCT Number: NCT04133376

Electronic Hookah and Endothelial Cell Function

Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the specific role of nicotine and the mechanisms by which it may impairs endothelial function remain understudied. The objective of this project is to investigate the specific role of nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.

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Key information

Conditions

Smoking Behavior Endothelial Dysfunction

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21-39 years old hookah smokers: smoked hookah >12x in last 12 months
  • 21-39 years old e-cigarette users: vaped >12x in last 12 months
  • no history of illicit drugs
  • no evidence of cardiopulmonary disease by history/ physical
  • no diabetes: fasting blood glucose <100 mg/dl
  • BP<140/90mmHg
  • resting HR<100 bpm
  • BMI<30kg•m2
  • no prescription medication

Exclusion criteria

  • exhaled CO>10 ppm (smoking non-abstinence)
  • positive pregnancy test
  • psychiatric illness

Treatment and study plan

Electronic hookah vaping with nicotine

Other

Participants will be invited to vape a 30-minute session of e-hookah containing nicotine

Electronic hookah vaping without nicotine

Other

Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine

Primary outcomes

  1. Flow-Mediated Dilation (FMD)

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Outcome variable reflecting FMD (brachial artery diameter) was recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.

  2. Acetylcholine-stimulated nitric oxide production

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Human umbilical vein endothelial cells were cultured with subjects' serum sampled before and after the vaping sessions and acetylcholine-stimulated nitric oxide production was assessed

  3. Basal reactive oxygen species bioactivity

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Human umbilical vein endothelial cells were cultured with participants' serum sampled before and after the vaping sessions and basal reactive oxygen species bioactivity was assessed

  4. Fibrinogen levels

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Plasma fibrinogen

  5. Heme oxygenase-1 assay

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Heme oxygenase-1 concentration assay

  6. paraoxonase-1 activity

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    paraoxonase-1 activity

  7. HDL protection assay

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    HDL protection assay, reflecting the ability of HDL to inhibit oxidation to LDL

  8. Nicotine levels

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Plasma nicotine

  9. Carbon monoxide levels

    Time frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions

    Exhaled carbon monoxide levels

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Official study title

The Effects of Electronic Hookah on Endothelial Cell Function: The Role of Nicotine

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 21, 2019
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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