Clinical trial NCT03573154: Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.
Official title: Nicotine Pharmacokinetic Study and Volatile Organic Compound Analysis in Exhaled Breath After Electronic Cigarette Utilization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electronic Cigarette
Keywords: nicotine
e-cigarette
exhaled breath
pharmacokinetic model
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of nicotine in blood at Baseline
timeFrame: At T0 (during the nicotine's absorption by the patient)
measure: Concentration of nicotine in blood at 10 minutes
timeFrame: At T10 min after the nicotine's absorption
measure: Concentration of nicotine in blood at 20 min
timeFrame: At T20 min after the nicotine's absorption
measure: Concentration of nicotine in blood at 40 min
timeFrame: At T40 min after the nicotine's absorption
measure: Concentration of nicotine in blood at 80 min
timeFrame: At T80 min after the nicotine's absorption
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbours
state: Grand EST
Study officials:
References: