Electronic Cigarette
Conditions
Keywords
nicotine, e-cigarette, exhaled breath, pharmacokinetic model
Brief summary
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.
Interventions
OTHERadministration of the liquid 1 and then the liquid 2
The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second
OTHERadministration of the liquid 2 and then the liquid 1
The patient will received the e-liquid 2 in the first visit and the e-liquid 1 in the second
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of nicotine in blood at Baseline | At T0 (during the nicotine's absorption by the patient) | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. |
| Concentration of nicotine in blood at 10 minutes | At T10 min after the nicotine's absorption | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. |
| Concentration of nicotine in blood at 20 min | At T20 min after the nicotine's absorption | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. |
| Concentration of nicotine in blood at 40 min | At T40 min after the nicotine's absorption | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. |
| Concentration of nicotine in blood at 80 min | At T80 min after the nicotine's absorption | Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method. |
Countries
France
Contacts
Primary ContactDaniel BRUMARU, MD
Backup ContactVéronique KEMMEL, MD
Outcome results
None listed