NCT02147665

Brief Summary

This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. Here the investigators will directly measure the acute effects of Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 13, 2020

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

April 30, 2014

Last Update Submit

January 9, 2020

Conditions

Keywords

Hookahwaterpipesmokingsympathetic

Outcome Measures

Primary Outcomes (1)

  • Sympathetic nerve activity

    Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.

    At the initial study visit

Secondary Outcomes (1)

  • Myocardial contrast echocardiography

    At the initial study visit

Other Outcomes (1)

  • Venous Occlusion Plethysmography

    At the initial study visit

Study Arms (1)

Hookah smoking

EXPERIMENTAL

Healthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after Hookah smoking.

Other: Hookah smoking

Interventions

Subjects will smoke waterpipe in a controlled research environment.

Hookah smoking

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 39 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:

  • Exhaled carbon monoxide level greater than 10 ppm\* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
  • History of cardiopulmonary disease
  • Use of any prescription medication with exception of oral contraceptive pills
  • History of psychiatric illness
  • History of neurologic disease
  • BMI ≥ 35
  • Evidence of any of the above by physical examination, ECG or echocardiogram
  • Smoked cigarette in the past 12 months
  • History of illicit drug use
  • Pregnant
  • Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Water Pipe SmokingSmoking

Interventions

Smoking Water Pipes

Condition Hierarchy (Ancestors)

Pipe SmokingBehavior

Intervention Hierarchy (Ancestors)

Smoking PipesSmoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ronald G Victor, 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
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 28, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 13, 2020

Record last verified: 2015-11

Locations