Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin

January 9, 2020 updated by: Cedars-Sinai Medical Center
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) 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. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine free hookah (herbal/steam stones) smoking
Healthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after nicotine free hookah smoking.
Other: Nicotine free hookah smoking
Subjects will smoke waterpipe in a controlled research environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sympathetic nerve activity
Time Frame: Change from baseline in sympathetic nerve activity at 1 hr
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.
Change from baseline in sympathetic nerve activity at 1 hr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in regional myocardial perfusion
Time Frame: Change from baseline in regional myocardial perfusion at 1 hr
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve.
Change from baseline in regional myocardial perfusion at 1 hr

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in leg blood flow
Time Frame: Change from baseline in leg blood flow at 1 hr
Lower leg blood flow will be measured with standard venous occlusion plethysmography.
Change from baseline in leg blood flow at 1 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Ronald G Victor, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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