Clinical Trial: Determination of Carcinogens Nicotine in Electronic Cigarettes Users

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Determination of Carcinogens Nicotine in Electronic Cigarettes Users

Brief Summary:

Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine").

The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.


Detailed Summary:

The study has only one visit taking place as below:

  • Verification of inclusion and non-inclusion criteria.
  • Collection of the informed consent of the subject Given the non-invasive nature of the procedure, a period of reflection will be given to the subjects, however, information and obtaining consent will be made during the same visit.
  • Collection of 5 mL of required for the pregnancy test in women of childbearing age. This collection does not need to be fasting. If this test is positive, the subject will not be included in the study.
  • Collection of 30 mL of urine needed for the cotinine and the NNN quantitative analysis.

This collection does not need to be fasting.

Then , the urine sample is divided into two vials stored at -80 ° C:

  • a 10 mL vial for the cotinine analysis,

  • a 20 mL vial for the NNN analysis.

    • Realization of the Fagerstrom test (FTCD) in order to evaluate subject smoking. This test is not done for the group 4 (group "without nicotine")
    • Measurement of carbon monoxide in exhaled air If after signing the consent, the subject realizes that he cannot urinate or he did not enough urine during the inclusion visiting, the subject can come back the next working day to make the urine collection.

Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment". [ Time Frame: At the inclusion ]

The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker" [ Time Frame: At the inclusion ]
    The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
  • NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine" [ Time Frame: At the inclusion ]
    The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
  • NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker" [ Time Frame: At the inclusion ]
    The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
  • NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine" [ Time Frame: At the inclusion ]
    The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 7, 2016
Date Started: September 2016
Date Completion: November 2017
Last Updated: September 7, 2016
Last Verified: August 2016