NCT03616002

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

5.2 years

First QC Date

January 13, 2015

Last Update Submit

February 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow-mediated dilation

    change from baseline to immediately after smoking

Secondary Outcomes (1)

  • Reactive hyperemia peripheral arterial tonometry

    change from baseline to immediately after smoking

Other Outcomes (2)

  • Pulse wave velocity

    change from baseline to immediately after smoking

  • aortic pressure waveform

    change from baseline to immediately after smoking

Study Arms (1)

Hookah smoking

EXPERIMENTAL

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

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

Hookah smoking

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Water Pipe Smoking

Interventions

Smoking Water Pipes

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehavior

Intervention Hierarchy (Ancestors)

Smoking PipesSmoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Florian Rader, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, M.Sc.

Study Record Dates

First Submitted

January 13, 2015

First Posted

August 6, 2018

Study Start

January 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations