Epidemiology and Acute Oral Effects Electronic Cigarette

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

Epidemiology and Acute Oral Effects of Electronic Cigarette

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011710
• Other study ID #: epidacute-ecig-2015
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 22, 2023

Study information

• Verified date: July 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes
• Tobacco Use Disorder

Intervention

Device:
• ProVari v2.5 (E-cigarette)
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)
Conventional cigarette
• Cigarette tip
Placebo device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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