Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking. (VAPexp'Air)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Electronic Cigarette
• Intervention / Treatment: Other: administration of the liquid 1 and then the liquid 2; Other: administration of the liquid 2 and then the liquid 1

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel BRUMARU, MD; Phone Number: +33 88 12 82 79; Email: daniel.brumaru@chru-strasbourg.fr
• Study Contact Backup: Name: Véronique KEMMEL, MD; Phone Number: +33 68 85 30 62; Email: veronique.kemmel@chru-strasbourg.fr

Study Locations

• France
  • Grand EST
    • Strasbourg, Grand EST, France, 67000
      • Recruiting
      • Hopitaux Universitaires de Strasbours
      • Contact: Daniel BRUMARU, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: e-liquid 1	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
OTHER: e-liquid 2	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2018
• Primary Completion (ANTICIPATED): June 15, 2022
• Study Completion (ANTICIPATED): August 3, 2022

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (ACTUAL): June 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: nicotine; exhaled breath; e-cigarette; pharmacokinetic model
• Other Study ID Numbers: 6911

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No