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TerminatedNCT03616002Updated Feb 4, 2021

Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

An interventional study of Hookah smoking in Hookah Smoking, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Other

Why this study was terminated
Due tot he Pandemic we decided to terminate this project.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years to 29 Years
Sex
All
01

Study summary

The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.

Read the detailed description

The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.

02

Conditions studied

  • Hookah Smoking
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 to 29 years of age
  • Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
  • Have not smoked cigarettes within the past 12 months

Exclusion criteria

Exclusion Criteria:

  • History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
  • Exhaled carbon monoxide level >10 ppm
  • BP \< 140/90 mmHg
  • BMI \<18.5 or > 30 kg•m2
  • Resting heart rate > 100 beats/min
  • Taking prescription medication
  • History of illicit drug use
  • Pregnant
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Hookah smoking

    Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking.

    Other: Hookah smoking

Interventions

  • OtherHookah smoking

    ad lib hookah smoking for 30 minutes in a controlled laboratory environment.

06

What researchers measure

Primary outcomes

  1. Brachial artery flow-mediated dilation

    Time frame: change from baseline to immediately after smoking

Secondary outcomes

  1. Reactive hyperemia peripheral arterial tonometry

    Time frame: change from baseline to immediately after smoking

Other outcomes

  1. Pulse wave velocity

    Time frame: change from baseline to immediately after smoking

  2. aortic pressure waveform

    Time frame: change from baseline to immediately after smoking

07

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
08

References and documents

Publications

  • Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, Rashid M, Davoren K, Moy NB, Doering L, Robbins W, Sarna L, Li N, Chang LC, Elashoff RM, Victor RG. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults. Circulation. 2019 May 7;139(19):2215-2224. doi: 10.1161/CIRCULATIONAHA.118.037375. PubMed 30764644 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03616002
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Los Angeles, University of California, San Francisco
Responsible party
Florian Rader (M.D, M.Sc., Cedars-Sinai Medical Center) — Principal investigator
First posted
Aug 6, 2018
Start date
Jan 1, 2015
Primary completion
Mar 2020
Completion
Mar 2020
Last update
Feb 4, 2021

Study contacts

Florian Rader, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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