Completed

NCT Number: NCT03011710

Epidemiology and Acute Oral Effects 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.

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.

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Key information

Conditions

Nicotine Dependence, Cigarettes Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

19 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProVari v2.5 (E-cigarette)

Device

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.

Other names: ProVari v2.5

Marlboro Gold (Conventional cigarette)

Device

Conventional cigarette

Other names: Marlboro Gold 0,6mg

Cigarette tip

Device

Placebo device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Epidemiology and Acute Oral Effects of Electronic Cigarette

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Jan 5, 2017
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed