Electronic Hookah and Endothelial Cell Function

NCT04133376 | Completed DMC

• 1 other identifier: T30IP1013
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (9)

• Flow-Mediated Dilation (FMD)

  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.

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

• Acetylcholine-stimulated nitric oxide production

  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

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

• Basal reactive oxygen species bioactivity

  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

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

• Fibrinogen levels

  Plasma fibrinogen

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

• Heme oxygenase-1 assay

  Heme oxygenase-1 concentration assay

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

• paraoxonase-1 activity

  paraoxonase-1 activity

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

• HDL protection assay

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

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

• Nicotine levels

  Plasma nicotine

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

• Carbon monoxide levels

  Exhaled carbon monoxide levels

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

Study Arms (2)

e-hookah vaping with nicotine

EXPERIMENTAL

Participants were invited to vape a 30-minute electronic hookah with nicotine vaping session, followed by a 30-minute electronic hookah without nicotine vaping session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.

Other: Electronic hookah vaping with nicotine; Other: Electronic hookah vaping without nicotine

e-hookah vaping without nicotine

EXPERIMENTAL

Participants were invited to vape a 30-minute electronic hookah without nicotine vaping session, followed by a 30-minute electronic hookah with nicotine vaping session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.

Other: Electronic hookah vaping with nicotine; Other: Electronic hookah vaping without nicotine

Interventions

Electronic hookah vaping without nicotine OTHER

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

e-hookah vaping with nicotine; e-hookah vaping without nicotine

Electronic hookah vaping with nicotine OTHER

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

e-hookah vaping with nicotine; e-hookah vaping without nicotine

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old hookah smokers: smoked hookah \>12x in last 12 months
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mary Rezk-Hanna, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: January 16, 2020
• Primary Completion: November 29, 2022
• Study Completion: May 29, 2023
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)