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

Phase 1

Terminated

• Conditions: Nicotine-free Hookah Smoking
• Interventions: Other: Nicotine free hookah smoking

• Registration Number: NCT02310373
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine free hookah (herbal/steam stones) smoking	Nicotine free hookah smoking	Healthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after nicotine free hookah smoking.

Primary Outcome Measures

Name	Time	Method
Change in sympathetic nerve activity	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.

Secondary Outcome Measures

Name	Time	Method
Change in regional myocardial perfusion	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States