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

Not Applicable

• Conditions: Electronic Cigarette

• 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

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-29
• Study Start: 2018-12-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-23
• Primary Completion: 2022-06-15
• Study Completion: 2022-08-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

Hopitaux Universitaires de Strasbours; 🇫🇷 Strasbourg, Grand EST, France