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

Investigating the Secondhand Effects of Hookah Smoking and Vaping

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Stiffness; Vaping; Hookah Smoking; Secondhand Aerosol
• Intervention / Treatment: Other: Combustible Hookah Smoke; Other: Electronic Hookah Aerosol; Other: Clean Room Air

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Rezk-Hanna, PhD; Phone Number: 310-206-8654; Email: MRHanna@mednet.ucla.edu
• Study Contact Backup: Name: Maria M Rivas; Phone Number: 310-862-2180; Email: MMonarresRivas@sonnet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-8361
      • Recruiting
      • University of California, Los Angeles
      • Contact: Primadya Sakti, B.A.; Phone Number: 310-562-4348; Email: psakti@sonnet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure to Combustible Hookah Smoke; Participants will be exposed to combustible hookah smoke. To mitigate the impact of carryover effects, the exposure sessions will be separated by a minimum of 7-days.	Other: Combustible Hookah Smoke; Exposure to combustible hookah smoke for a duration of 60 minutes.
Experimental: Exposure to Electronic Hookah Aerosol; Participants will be exposed to electronic hookah aerosol. To mitigate the impact of carryover effects, the exposure sessions will be separated by a minimum of 7-days.	Other: Electronic Hookah Aerosol; Exposure to electronic hookah aerosol for a duration of 60 minutes.
Experimental: Exposure to Clean Air; Participants will be exposed to Clean Room Air. To mitigate the impact of carryover effects, the exposure sessions will be separated by a minimum of 7-days.	Other: Clean Room Air; Exposure to room air for a duration of 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Arterial stiffness	Using applanation tonometry, pulse wave velocity will be used to measure cebtral arterial stiffness.	Pre- and post- the 60-minute exposure sessions

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: 20-001570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No