Epidemiology and Acute Oral Effects Electronic Cigarette

NCT ID: NCT03011710

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-11-22

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

E-cigarette with nicotine

Nicotine level: 6 mg/ml

Group Type: EXPERIMENTAL

ProVari v2.5 (E-cigarette)

Intervention Type: 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.

E-cigarette without nicotine

Nicotine level: 0 mg/ml

Group Type: EXPERIMENTAL

ProVari v2.5 (E-cigarette)

Intervention Type: 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.

Conventional cigarette

Nicotine content: 0,5mg

Group Type: EXPERIMENTAL

Marlboro Gold (Conventional cigarette)

Intervention Type: DEVICE

Conventional cigarette

Cigarette tip

Placebo device

Group Type: PLACEBO_COMPARATOR

Cigarette tip

Intervention Type: DEVICE

Placebo device

Interventions

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.

Intervention Type: DEVICE

Marlboro Gold (Conventional cigarette)

Conventional cigarette

Intervention Type: DEVICE

Cigarette tip

Placebo device

Intervention Type: DEVICE

Other Intervention Names

ProVari v2.5; Marlboro Gold 0,6mg

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

epidacute-ecig-2015

Identifier Type: -

Identifier Source: org_study_id