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

Nicotine-free Hookah Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02310373
• Other study ID #: Pro00037529
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• 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

Related Conditions & MeSH terms

• Nicotine-free Hookah Smoking

Intervention

Other:
• Nicotine free 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	Change in leg blood flow	Lower leg blood flow will be measured with standard venous occlusion plethysmography.	Change from baseline in leg blood flow at 1 hr
Primary	Change in 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.	Change from baseline in sympathetic nerve activity at 1 hr
Secondary	Change in regional myocardial perfusion	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