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

Electronic Cigarette Clinical Trial

— VAPexp'Air  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573154
• Other study ID #: 6911
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: August 3, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Strasbourg, France
• Contact: Daniel BRUMARU, MD
• Phone: +33 88 12 82 79
• Email: daniel.brumaru[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 3, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Electronic Cigarette

Intervention

Other:
• administration 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
• administration 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

Locations

Country	Name	City	State
France	Hopitaux Universitaires de Strasbours	Strasbourg	Grand EST

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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