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Trial record 10 of 767 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

Tracking Information
First Submitted Date  ICMJE December 11, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date December 23, 2015
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
Changes in Air Quality measured by an aethelometer [ Time Frame: 2 hours spent at hookah bar ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
Official Title  ICMJE Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COPD
Intervention  ICMJE
  • Other: Active smoking of Tobacco Hookah 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
Study Arms  ICMJE
  • Active Comparator: Hookah Smoking Group
    10 participants will smoke tobacco hookah for 2 hours
    Interventions:
    • Other: Active smoking of Tobacco Hookah for 2 hours
    • Other: Visit a win bar
  • Active Comparator: Hookah Secondhand Smoke Group
    10 individuals will be exposed to secondhand hookah tobacco smoke for 2 hours
    Interventions:
    • Other: Exposure to tobacco hookah second hand smoke
    • Other: Visit a win bar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2015)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638194
Other Study ID Numbers  ICMJE 14-00370
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Weitzman, MD NYU Langone Medical Center
PRS Account NYU Langone Health
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP