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Trial record 10 of 762 for:    Tobacco Smoke

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

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ClinicalTrials.gov Identifier: NCT02638194
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
COPD Other: Active smoking of Tobacco Hookah for 2 hours Other: Exposure to tobacco hookah second hand smoke Other: Visit a win bar Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : September 2015

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: Exposure to tobacco hookah second hand smoke
Other: Visit a win bar
Participants will visit a wine bar for food and/or drinks




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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. ]
  8. 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. ]
  9. 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. ]
  10. 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. ]
  11. 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. ]
  12. 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. ]
  13. 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. ]
  14. 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. ]
  15. 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. ]
  16. 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. ]

Secondary Outcome Measures :
  1. Changes in Air Quality measured by an aethelometer [ Time Frame: 2 hours spent at hookah bar ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638194


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Michael Weitzman, MD NYU Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02638194     History of Changes
Other Study ID Numbers: 14-00370
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NYU Langone Health:
Chronic Obstructive Pulmonary Disease (COPD)
smoking
secondhand smoke