Clinical trial NCT04133376: Electronic Hookah and Endothelial Cell Function
Official title: The Effects of Electronic Hookah on Endothelial Cell Function: The Role of Nicotine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Endothelial Dysfunction
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2019-10-21
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Flow-Mediated Dilation (FMD)
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Acetylcholine-stimulated nitric oxide production
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Basal reactive oxygen species bioactivity
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Fibrinogen levels
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Heme oxygenase-1 assay
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: paraoxonase-1 activity
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: HDL protection assay
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Nicotine levels
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Carbon monoxide levels
timeFrame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Mary Rezk-Hanna, PhD
role: PRINCIPAL_INVESTIGATOR
References: