Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.
- Conditions
- Electronic Cigarette
- Interventions
- Other: administration of the liquid 1 and then the liquid 2Other: administration of the liquid 2 and then the liquid 1
- Registration Number
- NCT03573154
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description e-liquid 1 administration of the liquid 1 and then the liquid 2 - e-liquid 2 administration of the liquid 2 and then the liquid 1 -
- Primary Outcome Measures
Name Time 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 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 80 min At T80 min after the nicotine's absorption Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopitaux Universitaires de Strasbours
🇫🇷Strasbourg, Grand EST, France