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

NCT ID: NCT02310373

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Nicotine-free Hookah Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine free hookah smoking

Intervention Type: OTHER

Subjects will smoke waterpipe in a controlled research environment

Interventions

Nicotine free hookah smoking

Subjects will smoke waterpipe in a controlled research environment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald G Victor

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00037529

Identifier Type: -

Identifier Source: org_study_id