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Determination of Carcinogens Nicotine in Electronic Cigarettes Users

NCT02897401 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-13

No results posted yet for this study

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.

Conditions

  • Smoking
  • Carcinogenesis of the Nicotine

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Patrick Dupont, MD · APHP, Paul Brousse Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897401 on ClinicalTrials.gov