Nicotine Dependence, CigarettesNCT03011710
Epidemiology and Acute Oral Effects Electronic Cigarette
A study testing ProVari v2.5 (E-cigarette), Marlboro Gold (Conventional cigarette) and Cigarette tip in people with Nicotine Dependence, Cigarettes, run by Semmelweis University.
Trial summary
Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- ProVari v2.5 (E-cigarette), Marlboro Gold (Conventional cigarette) and Cigarette tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 22 Nov 2023
- 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 19-49 years
- signed consent form
- smoking regularly e-cigarette and/or conventional cigarette for > half year
Who cannot join
- not pregnant and not planning pregnancy in the next 6 month
- BMI index < 30
- no severe parodontal disease
- no acute illness in the last 2 weeks
- no chronic disease (eg.: diabetes)
- no diet which can influence the oral pH
About this study
Official title: Epidemiology and Acute Oral Effects of Electronic Cigarette
Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use and awareness of these devices has grown exponentially in recent years, with millions of people currently using them.
The benefits and risks of electronic cigarette use are uncertain. There is no research on the acute oral effects of electronic cigarette in the scientific literature and no hungarian epidemiological survey has been performed in this topic.
Read more
Regulation of electronic cigarettes varies across countries in the European Union, ranging from no regulation to banning them entirely.
The investigators research could help to integrate the regulation of this device in Hungary and in the EU as well.
The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey would be novel in this topic.
Read the detailed description
The epidemiological survey is performed with online questionnaires, which are published on e-cigarette-selling websites and on other forums dealing with this topic.
The main outcome of interest was whether or not e-cigarette use helped people to quit smoking or reduce the number of conventional cigarettes. Participants were also asked about the reason for starting e-cigarette use. Nationality, habitation, citizenship status were included as demographic predictors in analyses.
Measurements of acute oral effects before and after using electronic cigarette with nicotine, without nicotine, conventional cigarette and placebo device:
- measurement of exhaled CO changes by Smokerlyzer piCO
- measurement of saliva MMP-8 by PerioSafe Home
- measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check Buffer Kit (GC)
- measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method)
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- ProVari v2.5 (E-cigarette), Marlboro Gold (Conventional cigarette), Cigarette tip
- Keywords
- e-cigarette, blood flow, oral effects, oral pH
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProVari v2.5 (E-cigarette)Device
Also called ProVari v2.5
An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.
Marlboro Gold (Conventional cigarette)Device
Also called Marlboro Gold 0,6mg
Conventional cigarette
Cigarette tipDevice
Placebo device
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette with nicotine | Experimental | Nicotine level: 6 mg/ml Receives: Device: ProVari v2.5 (E-cigarette) |
| E-cigarette without nicotine | Experimental | Nicotine level: 0 mg/ml Receives: Device: ProVari v2.5 (E-cigarette) |
| Conventional cigarette | Experimental | Nicotine content: 0,5mg Receives: Device: Marlboro Gold (Conventional cigarette) |
| Cigarette tip | Placebo comparator | Placebo device Receives: Device: Cigarette tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood flow after vaping/smoking
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.
Measured: baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startSep 2015
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011710
- Sponsor's protocol ID
- epidacute-ecig-2015
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Acute Oral Effects of Electronic Cigarette
- ClinicalTrials.gov ID
- NCT03011710
- Acronym / sponsor ID
- epidacute-ecig-2015
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- e-cigarette, blood flow, oral effects, oral pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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 cigarettes are battery-powered vaporizers which have a similar feel to tobacco smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use and awareness of these devices has grown exponentially in recent years, with millions of people currently using them.
The benefits and risks of electronic cigarette use are uncertain. There is no research on the acute oral effects of electronic cigarette in the scientific literature and no hungarian epidemiological survey has been performed in this topic.
Regulation of electronic cigarettes varies across countries in the European Union, ranging from no regulation to banning them entirely.
The investigators research could help to integrate the regulation of this device in Hungary and in the EU as well.
The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey would be novel in this topic.
Detailed description
The epidemiological survey is performed with online questionnaires, which are published on e-cigarette-selling websites and on other forums dealing with this topic.
The main outcome of interest was whether or not e-cigarette use helped people to quit smoking or reduce the number of conventional cigarettes. Participants were also asked about the reason for starting e-cigarette use. Nationality, habitation, citizenship status were included as demographic predictors in analyses.
Measurements of acute oral effects before and after using electronic cigarette with nicotine, without nicotine, conventional cigarette and placebo device:
- measurement of exhaled CO changes by Smokerlyzer piCO
- measurement of saliva MMP-8 by PerioSafe Home
- measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check Buffer Kit (GC)
- measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E-cigarette with nicotine | Experimental | Device: ProVari v2.5 (E-cigarette)Nicotine level: 6 mg/ml |
| E-cigarette without nicotine | Experimental | Device: ProVari v2.5 (E-cigarette)Nicotine level: 0 mg/ml |
| Conventional cigarette | Experimental | Device: Marlboro Gold (Conventional cigarette)Nicotine content: 0,5mg |
| Cigarette tip | Placebo comparator | Device: Cigarette tipPlacebo device |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age: 19-49 years
- signed consent form
- smoking regularly e-cigarette and/or conventional cigarette for > half year
Key exclusion criteria (6 listed)
- not pregnant and not planning pregnancy in the next 6 month
- BMI index < 30
- no severe parodontal disease
- no acute illness in the last 2 weeks
- no chronic disease (eg.: diabetes)
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 |
|---|---|---|
| ProVari v2.5 (E-cigarette)Also: ProVari v2.5An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings. | Device | E-cigarette with nicotine, E-cigarette without nicotine |
| Marlboro Gold (Conventional cigarette)Also: Marlboro Gold 0,6mgConventional cigarette | Device | Conventional cigarette |
| Cigarette tipPlacebo device | Device | Cigarette tip |
Primary outcome
Change from baseline in blood flow after vaping/smoking
Time frame: baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ProVari v2.5 (E-cigarette), Marlboro Gold (Conventional cigarette) and Cigarette tip in people with Nicotine Dependence, Cigarettes, run by Semmelweis University.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood flow after vaping/smoking (time frame: baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping). 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 29 Nov 2023.