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

NCT ID: NCT02638194

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COPD

Keywords

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Chronic Obstructive Pulmonary Disease (COPD) smoking secondhand smoke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hookah Smoking Group

10 participants will smoke tobacco hookah for 2 hours

Group Type ACTIVE_COMPARATOR

Active smoking of Tobacco Hookah for 2 hours

Intervention Type OTHER

Visit a win bar

Intervention Type OTHER

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

Hookah Secondhand Smoke Group

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

Group Type ACTIVE_COMPARATOR

Exposure to tobacco hookah second hand smoke

Intervention Type OTHER

Visit a win bar

Intervention Type OTHER

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

Interventions

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Active smoking of Tobacco Hookah for 2 hours

Intervention Type OTHER

Exposure to tobacco hookah second hand smoke

Intervention Type OTHER

Visit a win bar

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Weitzman, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-00370

Identifier Type: -

Identifier Source: org_study_id