Epidemiology and Acute Oral Effects Electronic Cigarette

NCT03011710 | Completed

• 1 other identifier: epidacute-ecig-2015
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nicotine Dependence, Cigarettes

Keywords

e-cigarette; blood flow; oral effects; oral pH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

E-cigarette with nicotine

EXPERIMENTAL

Nicotine level: 6 mg/ml

Device: ProVari v2.5 (E-cigarette)

E-cigarette without nicotine

EXPERIMENTAL

Nicotine level: 0 mg/ml

Device: ProVari v2.5 (E-cigarette)

Conventional cigarette

EXPERIMENTAL

Nicotine content: 0,5mg

Device: Marlboro Gold (Conventional cigarette)

Cigarette tip

PLACEBO COMPARATOR

Placebo device

Device: Cigarette tip

Interventions

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.

Also known as: ProVari v2.5

E-cigarette with nicotine; E-cigarette without nicotine

Marlboro Gold (Conventional cigarette) DEVICE

Conventional cigarette

Also known as: Marlboro Gold 0,6mg

Conventional cigarette

Cigarette tip DEVICE

Placebo device

Cigarette tip

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 19-49 years
• signed consent form
• smoking regularly e-cigarette and/or conventional cigarette for \> half year

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: September 1, 2015
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: November 29, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share