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Determination of Carcinogens Nicotine in Electronic Cigarettes Users (NCT02897401)

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.
  • Biological: pregnancy test
    Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.
    • Biological: urinary cotinine assesment
      Collection of 10 mL of urinary sample for cotinine analysis. The analysis is maid during the study and is centralised at the hospital Paul Brousse.
      • Biological: Urinary NNN assesement
        Collection of 20 mL of urinary sample for NNN analysis. The analysis is maid at the end of the study and is centralised in a laboratory located at Strasbourg.
        • Behavioral: Questionnaire (Fagerstrom test)
          This questionnaire will permit to assess the smoking habits of the participants.
          • Procedure: Measurement of carbon monoxide levels expired
            This test will permit to determinate if the participant are axposed to passive smoking or not.
            Ages eligible for Study
            18 Years and older
            Genders eligible for Study
            All
            Accepts Healthy Volunteers
            Accepts Healthy Volunteers
            Inclusion Criteria:
            • Group1:
            • Adults (18 years old and more)
            • Exclusive daily smoker for more than 4 weeks, consuming 10 manufactured cigarettes per day or more
            • With health insurance
            • Group 2:
            • Adults (18 years old and more)
            • Users of electronic cigarette EGO or MOD type for 4 weeks or more
            • Using a nicotine dosage of 12mg / ml or more for at least 4 weeks
            • Former smokers who consumed 10 cigarettes per day or more
            • Having completely stopped smoking for at least 4 weeks
            • No Subjected to passive smoking (verified by measuring carbon monoxide in exhaled air)
            • With health insurance
            • Group 3:
            • Adults (18 years old and more)
            • People in patch 21 mg / 24h or 25mg / 16h in the fourth week or more treatment
            • Without taking oral nicotine or electronic cigarette for at least 4 weeks
            • Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
            • Former smokers who consumed 10 cigarettes per day or more
            • Having completely stopped smoking for at least 4 weeks
            • With health insurance
            • Group 4 (control group):
            • Adults (18 years old and more)
            • People Non-smoking, non-users of electronic cigarette, non-users of nicotine replacement therapy for at least 4 weeks
            • Not subject to passive smoking (verified by measuring carbon monoxide in exhaled air)
            • With health insurance Patients in Groups 1, 2 and 3 must have a urinary cotinine ≥ 100 (ratio cotinine / creatinine - Determination Cotinine DRI). Patients in group 4 must have a urinary cotinine ≤ 10 (cotinine / creatinine ratio - Determination Cotinine DRI) The thresholds of carbon monoxide from clinical experience are:
            • Non current smoker: 0 to 5 parts per million (ppm)
            • Passive smoker: 6 to 9 ppm
            • Current active smoker : 10 ppm or more Non inclusion criteria
            • Rolling tobacco, cigars, cigarillos, pipe, bidi, chicha, cannabis smockers during the last 4 weeks
            • Users tobacco snuff or chewing tobacco during the last 4 weeks
            • Users of oral nicotine replacement therapy (gum, lozenges, inhalers, oral spray) during the last 4 weeks.
            • Users of drug for smoking cessation aid other than nicotinic treatment: Varenicline, Bupropion, clonidine, Cytisine during the last 4 weeks
            • Pregnant or breastfeeding women
            • Non-compliant or unable to follow directions
            • Refusing to sign the informed consent
            • Refusing to do the urine collection
            • Under guardianship or any other protective measures
            Exclusion Criteria:
            • Group 1, 2 and 3:
            • Having an urinary cotinine <100 (ratio cotinine / creatinine - Determination Cotinine DRI)
            • Group 4 (control group):
            • Having an urinary cotinine> 10 (ratio cotinine / creatinine - Determination Cotinine DRI) The determination of urinary cotinine levels will be carried out centrally. The result will not be available at the inclusion visit. The included patients who do not have the urinary cotinine levels required for their group, will secondarily excluded from the study. The number of subjects in Groups 1, 2 and 3 with a ratio of cotinine would be less than 100 is expected to be negligible.A102
            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.

            1 locations

            France (1)
            • APHP, Paul Brousse Hospital
              not yet recruiting
              Villejuif, France, 94800
            Status:
            not yet recruiting
            Type:
            Interventional
            Phase:
            -
            Start:
            31 August, 2016
            Updated:
            06 September, 2016
            Participants:
            80
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