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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02147665
Other study ID # Pro00031150
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date March 2016

Study information

Verified date November 2015
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Hookah smoking
Subjects will smoke waterpipe in a controlled research environment.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Venous Occlusion Plethysmography Lower leg blood flow will be measured with standard venous occlusion plethysmography. At the initial study visit
Primary 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 Myocardial contrast echocardiography Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve. At the initial study visit
See also
  Status Clinical Trial Phase
Completed NCT03723616 - Reactions to Warnings on Hookah Ads N/A
Recruiting NCT04661683 - Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol N/A
Terminated NCT03616002 - Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function 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