Electronic CigaretteVAPexp'AirNCT03573154
Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.
A study testing administration of the liquid 1 and then the liquid 2 and administration of the liquid 2 and then the liquid 1 in people with Electronic Cigarette, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette
- What is being tested?
- administration of the liquid 1 and then the liquid 2 and administration of the liquid 2 and then the liquid 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2018to 3 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Strasbours
Strasbourg, Grand Est, 67000
Daniel BRUMARU, PHD
About this study
Official title: 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.
- Conditions
- Electronic Cigarette
- Being tested
- administration of the liquid 1 and then the liquid 2, administration of the liquid 2 and then the liquid 1
- Keywords
- nicotine, e-cigarette, exhaled breath, pharmacokinetic model
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| e-liquid 1 | Other | Not described Receives: Other: administration of the liquid 1 and then the liquid 2 |
| e-liquid 2 | Other | Not described Receives: Other: administration of the liquid 2 and then the liquid 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of nicotine in blood at Baseline
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At T80 min after the nicotine's absorption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start19 Dec 2018
- Primary completion15 Jun 2022 (estimated)
- Study completion3 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic CigaretteStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573154
- Sponsor's protocol ID
- 6911
- Acronym
- VAPexp'Air
- Status last verified
- Dec 2021
- First submitted
- 11 Apr 2018
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Pharmacokinetic Study and Volatile Organic Compound Analysis in Exhaled Breath After Electronic Cigarette Utilization.
- ClinicalTrials.gov ID
- NCT03573154
- Acronym / sponsor ID
- VAPexp'Air / 6911
- Conditions
- Electronic Cigarette
- Keywords
- nicotine, e-cigarette, exhaled breath, pharmacokinetic model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 3 Aug 2022 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration of the liquid 1 and then the liquid 2The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second | Other | e-liquid 1 |
| administration of the liquid 2 and then the liquid 1The patient will received the e-liquid 2 in the first visit and the e-liquid 1 in the second | Other | e-liquid 2 |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of the liquid 1 and then the liquid 2 and administration of the liquid 2 and then the liquid 1 in people with Electronic Cigarette, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel BRUMARU, MD (+33 88 12 82 79, daniel.brumaru@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of nicotine in blood at Baseline (time frame: At T0 (during the nicotine's absorption by the patient)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.