Clinical trial NCT03690427: The Cardiovascular Effects of Electronic Hookah Vaping
Official title: Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Inflammation
Oxidative Stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Charcoal-heated hookah smoking vs. electronic hookah vaping
Primary purpose: OTHER

Brief summary: Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but scientific evidence is lacking. The study aims to elucidate the comparative effects of traditional hookah smoking vs. e-hookah vaping on human vascular and endothelial function; and examine the role of inflammation and oxidative stress, as likely mechanisms in hookah-related cardiovascular disease pathogenesis.

Detailed description: Hookah (water-pipe) tobacco smoking is rapidly increasing in popularity worldwide. Contributing to this popularity is the unsubstantiated belief that traditional charcoal-heated hookah smoke is detoxified as it passes through the water-filled basin. More recently, electronic (e-) hookahs-containing flavored e-liquid that is heated electrically but inhaled through traditional water-pipes-are increasing in popularity in the United States among young female adults, who endorse marketing claims that these products are even safer than traditional charcoal-heated hookah products. The objective of this project is to investigate the comparative effects of traditional charcoal-heated hookah smoking versus e-hookah vaping on endothelial and vascular function and their mechanistic role in the development of cardiovascular disease. The investigators will test the hypothesis that: 1) in the absence of burning charcoal briquettes and virtually any carbon monoxide (CO) exposure, e-hookah vaping acutely impairs endothelial function and evokes acute central arterial stiffness, opposite from the endothelial function augmentation observed after traditional charcoal-heated hookah smoking, which is likely mediated by the large CO boost emitted from burning charcoal briquettes used to heat the flavored hookah tobacco; and 2) the processes of oxidative stress and inflammation play a pivotal mechanistic role underlying these vascular changes. Accordingly, in a cross-over study comparing traditional hookah smoking to e-hookah vaping, the investigators will assess endothelial function measured by brachial artery flow-mediated dilation and aortic stiffness by pulse wave velocity and augmentation index in 18 young healthy hookah smokers 21-39 years old, before and after ad lib 30-minute smoking/ vaping exposure sessions. To test for oxidative stress mediation, the investigators will determine if any acute impairment in endothelial function after e-hookah can be prevented by intravenous Vitamin C infusion, a potent anti-oxidant. Inflammatory and oxidant biomarkers, as well as smoking exposure biomarkers will be collected before and after the exposure sessions. The results of this proposal: (a) stand to fill in gaps in our mechanistic understanding of the comparative effect of traditional vs. e-hookah bowl on vascular and endothelial function; and (b) help inform policy decisions by the FDA about regulation of hookah products.

Eligibility criteria: Inclusion Criteria:

* 21-39 years old hookah smokers: smoked hookah \>12x in last 12 months
* no history of illicit drugs or marijuana
* 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: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Carotid-Femoral Pulse Wave Velocity (Cf-PWV)
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: HDL Oxidant Index (HOI)
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Paraoxonase-1 (PON-1) Activity
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Arylesterase Activity
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions.
measure: High-sensitivity C-reactive Protein (Hs-CRP) Levels
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Tumor Necrosis Factor-α (TNFα) Concentrations
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Secondary outcomes:
measure: Flow-Mediated Dilation (FMD)
timeFrame: Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)
measure: Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)
timeFrame: Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.
measure: Augmentation Index (AI)
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Interleukin 6 (IL-6) Levels
timeFrame: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
measure: Interleukin 10 (IL-10) Levels
timeFrame: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).
measure: Nicotine Levels
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
measure: Carbon Monoxide (CO) Levels
timeFrame: Pre- and post- the 30-minute smoking or vaping exposure sessions
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
citation: Rezk-Hanna M, Gupta R, Nettle CO, Dobrin D, Cheng CW, Means A, Brecht ML, Tashkin DP, Araujo JA. Differential Effects of Electronic Hookah Vaping and Traditional Combustible Hookah Smoking on Oxidation, Inflammation, and Arterial Stiffness. Chest. 2022 Jan;161(1):208-218. doi: 10.1016/j.chest.2021.07.027. Epub 2021 Jul 21.
citation: Rezk-Hanna M, Seals DR, Rossman MJ, Gupta R, Nettle CO, Means A, Dobrin D, Cheng CW, Brecht ML, Mosenifar Z, Araujo JA, Benowitz NL. Ascorbic Acid Prevents Vascular Endothelial Dysfunction Induced by Electronic Hookah (Waterpipe) Vaping. J Am Heart Assoc. 2021 Feb;10(5):e019271. doi: 10.1161/JAHA.120.019271. Epub 2021 Feb 20.