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
Conditions
Study Type
Enrollment (Anticipated)
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
-
-
Grand EST
-
Strasbourg, Grand EST, France, 67000
- Recruiting
- Hopitaux Universitaires de Strasbours
-
Contact:
- Daniel BRUMARU, PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: e-liquid 1
|
The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second
|
|
OTHER: e-liquid 2
|
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
Time Frame: At T0 (during the nicotine's absorption by the patient)
|
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
Time Frame: At T10 min after the nicotine's absorption
|
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
Time Frame: At T20 min after the nicotine's absorption
|
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
Time Frame: At T40 min after the nicotine's absorption
|
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
Time Frame: At T80 min after the nicotine's absorption
|
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
|
At T80 min after the nicotine's absorption
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6911
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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