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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
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 4, 2017
    Last Updated
    October 5, 2017
    Sponsor
    Semmelweis University
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    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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