Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol

Vascular Stiffness Clinical Trial

Official title:

Investigating the Secondhand Effects of Hookah Smoking and Vaping

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661683
• Other study ID #: 20-001570
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Mary Rezk-Hanna, PhD
• Phone: 310-206-8654
• Email: MRHanna[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the United States, secondhand smoke is the third leading preventable cause of death. Flavored hookah (waterpipe) tobacco smoking, a highly social activity common in hookah bars, is a key source of SHS exposure. While smoke-free air laws have decreased exposure to secondhand smoke, the majority of laws do not include hookah smoking. Thus, as a social outlet for youth and young adults, hookah smoke exposure may harm non-smokers, including women of reproductive age or pregnant, hookah bar workers, children, and individuals with heart and lung disease. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, little is known about the acute vascular effects of secondhand exposure to hookah smoke and aerosol. The study aims to examine the acute effects of secondhand exposure of hookah smoke and aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 49 Years

Eligibility

Inclusion Criteria:

• 21-49 years old
• Never a smoker: do not use any tobacco products or nicotine delivery systems, including cigarettes, cigars (traditional and filtered), cigarillos, hookah, smokeless tobacco (i.e., loose snus, moist snuff, dip, spit, or chewing tobacco), pipe tobacco, snus pouches, dissolvable tobacco or vaping.
• no evidence of cardiopulmonary disease by history/physical
• blood pressure (BP) < 140/90 mmHg
• resting heart rate (HR) < 100 bpm
• BMI >18 or < 30kg•m2
• no prescription medication
• No exposure to environmental tobacco smoke for at least one week prior to the study date.

Exclusion Criteria:

• exhaled carbon monoxide >6 ppm
• (+) pregnancy test
• other conditions deemed unsafe to participate, such as breastfeeding

Related Conditions & MeSH terms

• Hookah Smoking
• Vaping
• Vascular Stiffness

Intervention

Other:
• Combustible Hookah Smoke
Exposure to combustible hookah smoke for a duration of 60 minutes.
• Electronic Hookah Aerosol
Exposure to electronic hookah aerosol for a duration of 60 minutes.
• Clean Room Air
Exposure to room air for a duration of 60 minutes.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-Mediated Dilation (FMD)	Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, will be used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity will be recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.	Pre- and post- the 60-minute exposure sessions
Primary	Arterial stiffness	Using applanation tonometry, pulse wave velocity will be used to measure cebtral arterial stiffness.	Pre- and post- the 60-minute exposure sessions