Epidemiology and Acute Oral Effects Electronic Cigarette

Study Overview
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Brief Summary
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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
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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)

Official Title
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Epidemiology and Acute Oral Effects of Electronic Cigarette

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Device: ProVari v2.5 (E-cigarette)
* Device: Marlboro Gold (Conventional cigarette)
* Device: Cigarette tip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 19-49 years signed consent form smoking regularly e-cigarette and/or conventional cigarette for > half year Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette with nicotine<br>Nicotine level: 6 mg/ml | Device: ProVari v2.5 (E-cigarette)<br>* 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.<br>* Other names: ProVari v2.5;|
| Experimental: E-cigarette without nicotine<br>Nicotine level: 0 mg/ml | Device: ProVari v2.5 (E-cigarette)<br>* 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.<br>* Other names: ProVari v2.5;|
| Experimental: Conventional cigarette<br>Nicotine content: 0,5mg | Device: Marlboro Gold (Conventional cigarette)<br>* Conventional cigarette<br>* Other names: Marlboro Gold 0,6mg;|
| Placebo Comparator: Cigarette tip<br>Placebo device | Device: Cigarette tip<br>* Placebo device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette, blood flow, oral effects, oral pH