Spots Global Cancer Trial Database for Determination of Carcinogens Nicotine in Electronic Cigarettes Users

Study Description

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 Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Contact Details

Useful links and downloads for this trial