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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638194
• Other study ID #: 14-00370
• Status: Completed
• Phase: N/A
• First received: December 11, 2015
• Last updated: December 18, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Active smoking of Tobacco Hookah for 2 hours

• Exposure to tobacco hookah second hand smoke

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	Changes in Air Quality measured by an aethelometer		2 hours spent at hookah bar	No