Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars

The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Active smoking of Tobacco Hookah for 2 hours; Other: Visit a win bar; Other: Exposure to tobacco hookah second hand smoke

Detailed Description

A total of 20 participants are going to be enrolled in this study; 10 participants smoke hookah and 10 participants are exposed to second hand hookah smoke for 2 hours in NYC hookah bars. Subjects in the control group will also be paired as they were for the hookah bar visit but will visit a control location, where they will be asked to consume a similar amount of food and drink at a wine bar. Pulmonary function, cardiovascular changes, and blood and urine markers of inflammatory mediators before, immediately after and 24 hours after the participants' visits to hookah bars and wine bars will be examined. Air quality monitoring will also be performed at the hookah bar and at the control location. Physiological changes will be assessed by measuring pulmonary function, blood pressure, heart rate, and blood oxygenation status. To determine the extent of tobacco exposure and associated inflammatory changes from secondhand hookah smoke, investigators will measure blood inflammatory biomarkers, oxidative stress, gene expression, tobacco-related carcinogenic metabolites, and exhaled carbon dioxide levels.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Competent adult English speaking subjects
• Have used hookah in the past

Exclusion Criteria:

• Age <21
• Pregnancy
• Current cigarette smokers
• Has pulmonary disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD)
• Subjects are unable to give voluntary informed consent because they are non English speaking, are unable to read or write, or any other impediments that prohibits giving written informed consent
• Recent nasal surgery (within 6 months)
• History of bleeding or other blood related disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hookah Smoking Group; 10 participants will smoke tobacco hookah for 2 hours	Other: Active smoking of Tobacco Hookah for 2 hours; Other: Visit a win bar; Participants will visit a wine bar for food and/or drinks
Active Comparator: Hookah Secondhand Smoke Group; 10 individuals will be exposed to secondhand hookah tobacco smoke for 2 hours	Other: Visit a win bar; Participants will visit a wine bar for food and/or drinks; Other: Exposure to tobacco hookah second hand smoke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer	subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
Changes in Heart Rate measured by a portable monitor worn during encounters	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in blood oxygenation levels measured by a pulse oximeter	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker endothelin	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-10	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-8	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-6	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker CRP	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-1a	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IFN-g	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker TNF-a	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker GM-CSF	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker E-selectin	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker thrombomodulin	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker vWF	subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Air Quality measured by an aethelometer	2 hours spent at hookah bar

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael Weitzman, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: smoking; secondhand smoke; Chronic Obstructive Pulmonary Disease (COPD)
• Other Study ID Numbers: 14-00370

Plan for Individual participant data (IPD)

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