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Electronic Hookah and Endothelial Cell Function

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ClinicalTrials.gov Identifier: NCT04133376
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Mary Rezk-Hanna, PhD, University of California, Los Angeles

Brief Summary:
Electronic nicotine delivery systems (ENDS) are a new rapidly growing global epidemic. More recently, electronic (e-) hookahs, have increased in popularity in the United States, with the greatest uptake by young female adults, who endorse marketing claims that these products are safer alternatives to traditional flavored hookah tobacco smoking. Unlike other ENDS such as e-cigarettes, e-hookah bowls 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-hookah bowls' 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-hookah bowl delivers flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. The objective of this project is to investigate the effects of e-hookah bowl inhalation on endothelial function, vascular biomarkers and volatile compounds; and molecular mechanisms underlying e-hookah induced endothelial injury using freshly harvested human endothelial cells with a specific role of nicotine. In a cross-over study design, the investigators will first assess endothelial function measured by brachial artery flow-mediated dilation and markers of oxidative stress and inflammation in 18 young healthy hookah smokers 21-39 years old, before and after two separate 30-minute e-hookah bowl inhalation sessions using one brand of nicotine-containing and nicotine-free e-hookah liquid and, for control comparison, before and after sham hookah smoking. Then, in freshly harvested venous endothelial cells the investigators will assess nitric oxide bioavailability, and expression of markers of inflammation and oxidative stress before and after the sessions. To compare specific exposures across conditions, the research team will measure changes in plasma nicotine, and highly specific urinary mercapturic acid metabolites of acrolein and benzene. This proposed study will provide critical scientific data on the impact of e-hookah inhalation on vascular health and mechanisms of exposure on known cardiac risk factors. Results will provide critical data to the FDA to inform the development of regulations specific to hookah.

Condition or disease Intervention/treatment Phase
Smoking Endothelial Dysfunction Other: Electronic Hookah Inhalation (+ nicotine) Other: Electronic Hookah Inhalation (- nicotine) Other: Sham Inhalation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Electronic Hookah on Endothelial Cell Function: The Role of Nicotine
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vascular Endothelial Function Other: Electronic Hookah Inhalation (+ nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah containing nicotine

Other: Electronic Hookah Inhalation (- nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah not containing nicotine

Other: Sham Inhalation
Participants will be instructed to inhale a 30-minute sham session

Experimental: Biomarkers of oxidative stress and inflammation Other: Electronic Hookah Inhalation (+ nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah containing nicotine

Other: Electronic Hookah Inhalation (- nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah not containing nicotine

Other: Sham Inhalation
Participants will be instructed to inhale a 30-minute sham session

Experimental: Vascular endothelial cells Other: Electronic Hookah Inhalation (+ nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah containing nicotine

Other: Electronic Hookah Inhalation (- nicotine)
Participants will be instructed to inhale a typical 30-minute session of e-hookah not containing nicotine

Other: Sham Inhalation
Participants will be instructed to inhale a 30-minute sham session




Primary Outcome Measures :
  1. Changes of Endothelial function [ Time Frame: 30 minutes ]
    ∆Flow-Mediated Dilation (FMD), % from pre- to post- cuff occlusion performed before and after each exposure experiment.

  2. Changes in biomarkers of oxidative stress and inflammation. [ Time Frame: 30 minutes ]
    ∆plasma 8-iso-prostaglandin F2α before and after each exposure experiment.

  3. Changes in biomarkers of oxidative stress and inflammation. [ Time Frame: 30 minutes ]
    ∆plasma fibrinogen before and after each exposure experiment.

  4. Changes in biomarkers of oxidative stress and inflammation. [ Time Frame: 30 minutes ]
    ∆plasma oxidized LDL before and after each exposure experiment.

  5. Changes in endothelial cell function [ Time Frame: 30 minutes ]
    ∆nitric oxide bioavailability before and after each exposure experiment.

  6. Changes in endothelial cell function [ Time Frame: 30 minutes ]
    ∆nuclear factor-ĸB activation before and after each exposure experiment.

  7. Changes in endothelial cell function [ Time Frame: 30 minutes ]
    ∆nitrotyrosine before and after each exposure experiment.



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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-39 years old hookah smokers: smoked hookah >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133376


Contacts
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Contact: Steven Mann, BA 310-562-4348 Stevenmann@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Westwood, California, United States, 90024
Contact: Steven Mann, BA       Stevenmann@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Tobacco Related Disease Research Program
Investigators
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Principal Investigator: Mary Rezk-Hanna, PhD University of California, Los Angeles
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Responsible Party: Mary Rezk-Hanna, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04133376    
Other Study ID Numbers: T30IP1013
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action