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

U

University Hospital, Strasbourg, France

Status

Unknown

Conditions

Electronic Cigarette

Treatments

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

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

e-liquid 1
Other group
Treatment:
Other: administration of the liquid 1 and then the liquid 2
e-liquid 2
Other group
Treatment:
Other: administration of the liquid 2 and then the liquid 1

Trial contacts and locations

1

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Central trial contact

Véronique KEMMEL, MD; Daniel BRUMARU, MD

Data sourced from clinicaltrials.gov

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