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Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.

NCT ID: NCT03573154

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2022-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Electronic Cigarette

Keywords

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nicotine e-cigarette exhaled breath pharmacokinetic model

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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e-liquid 1

Group Type OTHER

administration of the liquid 1 and then the liquid 2

Intervention Type OTHER

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

e-liquid 2

Group Type OTHER

administration of the liquid 2 and then the liquid 1

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopitaux Universitaires de Strasbours

Strasbourg, Grand Est, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Daniel BRUMARU, MD

Role: CONTACT

Phone: +33 88 12 82 79

Email: [email protected]

Véronique KEMMEL, MD

Role: CONTACT

Phone: +33 68 85 30 62

Email: [email protected]

Facility Contacts

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Daniel BRUMARU, PHD

Role: primary

Other Identifiers

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6911

Identifier Type: -

Identifier Source: org_study_id