Open Actively Recruiting

Electronic Hookah and Endothelial Cell Function

About

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.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
21 Years
Maximum Age
39 Years

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
19-001426
Category
Lung/Respiratory Disorders
Principal Investigator
MARY REZK-HANNA
Contact
AMANDA ADOLFO
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04133376
For detailed technical eligibility, visit ClinicalTrials.gov.