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Determination of Carcinogens Nicotine in Electronic Cigarettes Users (CANICE)

Primary Purpose

Smoking, Carcinogenesis of the Nicotine

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pregnancy test
urinary cotinine assesment
Urinary NNN assesement
Questionnaire (Fagerstrom test)
Measurement of carbon monoxide levels expired
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring urinary N'Nitrosonornicotine, nicotine, electronic cigarette, nicotine remplacement treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • APHP, Paul Brousse Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Smocker

Electronic cigarette

Nicotine replacement therapy

Without nicotine

Arm Description

Cigarette consumption in the context of their habit (not related to the particiapion under study).

Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).

Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study).

No consumption in the context of their habit (not related to the particiapion under study).

Outcomes

Primary Outcome Measures

NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.

Secondary Outcome Measures

NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"
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"
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"
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"
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.

Full Information

First Posted
September 7, 2016
Last Updated
September 7, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02897401
Brief Title
Determination of Carcinogens Nicotine in Electronic Cigarettes Users
Acronym
CANICE
Official Title
Determination of Carcinogens Nicotine in Electronic Cigarettes Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Carcinogenesis of the Nicotine
Keywords
urinary N'Nitrosonornicotine, nicotine, electronic cigarette, nicotine remplacement treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smocker
Arm Type
Experimental
Arm Description
Cigarette consumption in the context of their habit (not related to the particiapion under study).
Arm Title
Electronic cigarette
Arm Type
Experimental
Arm Description
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
Arm Title
Nicotine replacement therapy
Arm Type
Experimental
Arm Description
Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study).
Arm Title
Without nicotine
Arm Type
Placebo Comparator
Arm Description
No consumption in the context of their habit (not related to the particiapion under study).
Intervention Type
Biological
Intervention Name(s)
pregnancy test
Intervention Description
Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.
Intervention Type
Biological
Intervention Name(s)
urinary cotinine assesment
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Urinary NNN assesement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire (Fagerstrom test)
Intervention Description
This questionnaire will permit to assess the smoking habits of the participants.
Intervention Type
Procedure
Intervention Name(s)
Measurement of carbon monoxide levels expired
Intervention Description
This test will permit to determinate if the participant are axposed to passive smoking or not.
Primary Outcome Measure Information:
Title
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
Description
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Time Frame
At the inclusion
Secondary Outcome Measure Information:
Title
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"
Description
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Time Frame
At the inclusion
Title
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"
Description
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Time Frame
At the inclusion
Title
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"
Description
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Time Frame
At the inclusion
Title
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"
Description
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
Time Frame
At the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick DUPONT, MD
Phone
01.45.59.69.25
Email
patrick.dupont@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Dupont, MD
Organizational Affiliation
APHP, Paul Brousse Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP, Paul Brousse Hospital
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Dupont, Dr
Phone
01.45.59.69.25
Email
patrick.dupont@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determination of Carcinogens Nicotine in Electronic Cigarettes Users

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