Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.

Study Overview
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Brief Summary
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Electronic or e-cigarettes are battery-powered devices that deliver vapor which may be inhaled in the manner tobacco is smoked. The e-liquid is usually a solution containing propylene glycol and/or vegetable glycerin, nicotine, and flavor concentrates, although some e-liquids also are sold as non-nicotine containing products. The long- and short-term public health consequences of e-cigarette use, including the effects of e-cigarettes on tobacco use behavior, are not well understood. However, the prevalence of e-cigarette use appears to be undergoing a rapid increase. In this study the investigators propose to analyze nicotine pharmacokinetic in blood and to compare the exhaled breath before and after e-cigarette smoking. They want to obtain a pharmacokinetic model of this population for nicotine. And they want to identify if molecules contained in vapor are absorbed, metabolized or modified by the organism.

Official Title
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Nicotine Pharmacokinetic Study and Volatile Organic Compound Analysis in Exhaled Breath After Electronic Cigarette Utilization.

Conditions
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Electronic Cigarette

Intervention / Treatment
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* Other: administration of the liquid 1 and then the liquid 2
* Other: administration of the liquid 2 and then the liquid 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who has already used electronic cigarette Subject who has been using electronic cigarette for more than one month and/or Tobacco smoker (traditional cigarettes) Subject without history of chronic pathology Subject not taking long-term drug treatment Subject able to understand studie's aims and risk Exclusion Criteria: Subject with a chronic respiratory pathology Subject suffering from a respiratory or acute otorhinolaryngology pathology in progress or recent Subject under alcohol withdrawal Subject with heavy drinking or daily use of illegal drugs Subject with epilepsy Subject having hypersensitivity to one of the compounds of the spraying liquid Subject with liver failure Subject with severe renal impairment (GFR <60 ml / min) Subject with an allergy to the molecules contained in the e-liquid Subject suffering from claustrophobia Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: e-liquid 1<br> | Other: administration of the liquid 1 and then the liquid 2<br>* The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second<br>|
| Other: e-liquid 2<br> | Other: administration of the liquid 2 and then the liquid 1<br>* The patient will received the e-liquid 2 in the first visit and the e-liquid 1 in the second<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of nicotine in blood at Baseline | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. | At T0 (during the nicotine's absorption by the patient) | 
| Concentration of nicotine in blood at 10 minutes | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. | At T10 min after the nicotine's absorption | 
| Concentration of nicotine in blood at 20 min | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. | At T20 min after the nicotine's absorption | 
| Concentration of nicotine in blood at 40 min | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. | At T40 min after the nicotine's absorption | 
| Concentration of nicotine in blood at 80 min | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. | At T80 min after the nicotine's absorption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine, e-cigarette, exhaled breath, pharmacokinetic model