NCT03573154

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

3.5 years

First QC Date

April 11, 2018

Last Update Submit

December 7, 2021

Conditions

Electronic Cigarette

Keywords

nicotinee-cigaretteexhaled breathpharmacokinetic model

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

e-liquid 1

OTHER
Other: administration of the liquid 1 and then the liquid 2

e-liquid 2

OTHER
Other: administration of the liquid 2 and then the liquid 1

Interventions

administration of the liquid 1 and then the liquid 2OTHER

The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second

e-liquid 1
administration of the liquid 2 and then the liquid 1OTHER

The patient will received the e-liquid 2 in the first visit and the e-liquid 1 in the second

e-liquid 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopitaux Universitaires de Strasbours

Strasbourg, Grand Est, 67000, France

RECRUITING

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Central Study Contacts

Daniel BRUMARU, MD

CONTACT

+33 88 12 82 79daniel.brumaru@chru-strasbourg.fr

Véronique KEMMEL, MD

CONTACT

+33 68 85 30 62veronique.kemmel@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

June 29, 2018

Study Start

December 19, 2018

Primary Completion

June 15, 2022

Study Completion

August 3, 2022

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations

FR(1)