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Completed

NCT Number: NCT02147665

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

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.

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Key information

Conditions

Hookah Smoking Behavior Pipe Smoking Smoking Water Pipe Smoking

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hookah smoking

Other

Subjects will smoke waterpipe in a controlled research environment.

Primary outcomes

  1. Sympathetic nerve activity

    Time frame: At the initial study visit

    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.

Secondary outcomes

  1. Myocardial contrast echocardiography

    Time frame: At the initial study visit

    Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve.

Other outcomes

  1. Venous Occlusion Plethysmography

    Time frame: At the initial study visit

    Lower leg blood flow will be measured with standard venous occlusion plethysmography.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 28, 2014
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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