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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.
The study has only one visit taking place as below:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smocker | Experimental | Cigarette consumption in the context of their habit (not related to the particiapion under study). |
|
| Electronic cigarette | Experimental | Electronic cigarette consumption in the context of their habit (not related to the particiapion under study). |
|
| Nicotine replacement therapy | Experimental | Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study). |
|
| Without nicotine | Placebo Comparator | No consumption in the context of their habit (not related to the particiapion under study). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregnancy test | Biological | Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the inclusion |
| NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine" |
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Inclusion Criteria:
Group1:
Group 2:
Group 3:
Group 4 (control group):
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 inclusion criteria
Exclusion Criteria:
Group 1, 2 and 3:
-Having an urinary cotinine <100 (ratio cotinine / creatinine - Determination Cotinine DRI)
Group 4 (control group):
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick DUPONT, MD | Contact | 01.45.59.69.25 | patrick.dupont@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Dupont, MD | APHP, Paul Brousse Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP, Paul Brousse Hospital | Villejuif | 94800 | France |
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| urinary cotinine assesment | Biological | 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. |
|
| Urinary NNN assesement | Biological | 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. |
|
| Questionnaire (Fagerstrom test) | Behavioral | This questionnaire will permit to assess the smoking habits of the participants. |
|
| Measurement of carbon monoxide levels expired | Procedure | This test will permit to determinate if the participant are axposed to passive smoking or not. |
|
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate. |
| At the inclusion |
| 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. | At the inclusion |
| 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. | At the inclusion |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011258 | Pregnancy Tests |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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