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

December 18, 2015 updated by: NYU Langone Health
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer
Time Frame: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
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
Time Frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in Air Quality measured by an aethelometer
Time Frame: 2 hours spent at hookah bar
2 hours spent at hookah bar

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Weitzman, MD, NYU Langone Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-00370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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