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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03616002
Other study ID # Pro00036547
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date March 2020

Study information

Verified date February 2021
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 58
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center University of California, Los Angeles, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Pulse wave velocity change from baseline to immediately after smoking
Other aortic pressure waveform change from baseline to immediately after smoking
Primary Brachial artery flow-mediated dilation change from baseline to immediately after smoking
Secondary Reactive hyperemia peripheral arterial tonometry change from baseline to immediately after smoking
See also
  Status Clinical Trial Phase
Completed NCT03723616 - Reactions to Warnings on Hookah Ads N/A
Completed NCT02147665 - Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin N/A
Recruiting NCT04661683 - Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol N/A
Completed NCT03096860 - Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure N/A
Completed NCT03595280 - Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults N/A