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

NCT02638194 | Completed

• 1 other identifier: 14-00370
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease (COPD); smoking; secondhand smoke

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (1)

• Changes in Air Quality measured by an aethelometer

  2 hours spent at hookah bar

Study Arms (2)

Hookah Smoking Group

ACTIVE COMPARATOR

10 participants will smoke tobacco hookah for 2 hours

Other: Active smoking of Tobacco Hookah for 2 hours; Other: Visit a win bar

Hookah Secondhand Smoke Group

ACTIVE COMPARATOR

10 individuals will be exposed to secondhand hookah tobacco smoke for 2 hours

Other: Exposure to tobacco hookah second hand smoke; Other: Visit a win bar

Interventions

Active smoking of Tobacco Hookah for 2 hours OTHER

Hookah Smoking Group

Exposure to tobacco hookah second hand smoke OTHER

Hookah Secondhand Smoke Group

Visit a win bar OTHER

Participants will visit a wine bar for food and/or drinks

Hookah Secondhand Smoke Group; Hookah Smoking Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Michael Weitzman, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 23, 2015
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)