Epidemiology and Acute Oral Effects Electronic Cigarette
Primary Purpose
Nicotine Dependence, Cigarettes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProVari v2.5 (E-cigarette)
Marlboro Gold (Conventional cigarette)
Cigarette tip
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence, Cigarettes focused on measuring e-cigarette, blood flow, oral effects, oral pH
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
E-cigarette with nicotine
E-cigarette without nicotine
Conventional cigarette
Cigarette tip
Arm Description
Nicotine level: 6 mg/ml
Nicotine level: 0 mg/ml
Nicotine content: 0,5mg
Placebo device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011710
Brief Title
Epidemiology and Acute Oral Effects Electronic Cigarette
Official Title
Epidemiology and Acute Oral Effects of Electronic Cigarette
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes
Keywords
e-cigarette, blood flow, oral effects, oral pH
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-cigarette with nicotine
Arm Type
Experimental
Arm Description
Nicotine level: 6 mg/ml
Arm Title
E-cigarette without nicotine
Arm Type
Experimental
Arm Description
Nicotine level: 0 mg/ml
Arm Title
Conventional cigarette
Arm Type
Experimental
Arm Description
Nicotine content: 0,5mg
Arm Title
Cigarette tip
Arm Type
Placebo Comparator
Arm Description
Placebo device
Intervention Type
Device
Intervention Name(s)
ProVari v2.5 (E-cigarette)
Other Intervention Name(s)
ProVari v2.5
Intervention Description
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
Intervention Name(s)
Marlboro Gold (Conventional cigarette)
Other Intervention Name(s)
Marlboro Gold 0,6mg
Intervention Description
Conventional cigarette
Intervention Type
Device
Intervention Name(s)
Cigarette tip
Intervention Description
Placebo device
Primary Outcome Measure Information:
Title
Change from baseline in blood flow after vaping/smoking
Description
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.
Time Frame
baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Epidemiology and Acute Oral Effects Electronic Cigarette
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