Trial document




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  DRKS00017432

Trial Description

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Title

Intake behavior of nicotine in venous blood in electric cigarettes in the acute phase

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Trial Acronym

Nico-Tide

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URL of the Trial

http://www.nicotide.de

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Brief Summary in Lay Language

Electronic Cigarettes (E-Cigarettes, Electronic Nicotine Delivery Systems -ENDS) have been available on the German market since 2006. They enjoy increasing popularity and now have an immense market share with a very large variety of products. The latest development in e-cigarette technology, from the developer PAX Labs, is the JUUL vaporizer. "JUULing" is the term used when using the JUUL vaporizer. The JUUL is sold since 2015 in the US with very large sales and can be purchased since December 2018 in Germany. In particular, the manufacturer is campaigning to improve the lives of adult smokers worldwide. This is done by switching from the conventional flammable tobacco cigarette to its user-friendly alternative Juul. The nicotine experience in use is described as similar. Alarming and in contrast to the o.g. According to the manufacturer, the JUUL vaporizer seems to be made up of a large proportion of young people, mostly non-smokers. Thus, the question arises whether this e-cigarette could be an entry-level drug, especially for teenagers.
The Juul vaporizer is visually similar to a USB stick and is charged via USB ports. It uses nicotine cartridges or "pods" that are available in a variety of flavors (including Mint, Mango, Royal Cream, Apple, Rich Tobacco). Essentially, these contain glycerol, propylene glycol, natural oils, extracts and flavor, nicotine and benzoic acid. Especially in this vaporizer is the high nicotine concentration, which is in Germany at 1.7% nicotine (20 mg / ml) in the US even at 5% (59 mg / ml) nicotine. Presumably, when using Juul, the Nikotion will absorb faster and in higher doses than conventional e-cigarettes, suggesting a higher addictive potential.
That's exactly what we want to examine in our study. According to the study protocol, in the first 5 min of a standardized use of Juul blood should be taken and its concentration of nicotine determined. As a control, the same procedure is applied to smokers while smoking a conventional tobacco cigarette. The laboratory chemical analyzes are carried out by the colleagues of the Federal Institute for Risk Assessment, Max-Dohrn-Strasse 8-10 in 10589 Berlin. The study is complementary to our study published in 2017: "Nicotine delivery efficiency of first- and second-generation e-cigarettes and its impact on relief of craving during the acute phase of use" (T. Rüther et al International Journal of Hygiene and Environmental Health 2017)
With this study, we want to make a small contribution to the objective consideration of the product JUUL, in order to possibly be able to provide a risk assessment regarding the addictive potential, from which recommendations for action for users, patients and addiction therapists could be derived.

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Brief Summary in Scientific Language

Electronic Cigarettes (E-Cigarettes, Electronic Nicotine Delivery Systems -ENDS) have been available on the German market since 2006. They enjoy increasing popularity and now have an immense market share with a very large variety of products.
The latest development in e-cigarette technology, from the developer PAX Labs, is the JUUL vaporizer. "JUULing" is the term used when using the JUUL vaporizer. The JUUL is sold since 2015 in the US with very large sales and can be purchased since December 2018 in Germany. In particular, the manufacturer is campaigning to improve the lives of adult smokers worldwide. This is done by switching from the conventional flammable tobacco cigarette to its user-friendly alternative Juul. The nicotine experience in use is described as similar.
Alarming and in contrast to the o.g. According to the manufacturer, the JUUL vaporizer seems to be made up of a large proportion of young people, mostly non-smokers. Thus, especially in the case of the JUUL, the question that has been discussed since the market introduction of the ENDS, namely whether this form of ENDS can be regarded as a cessation aid for existing tobacco dependence or rather as an entry-level drug, especially for young people.
The Juul vaporizer is visually similar to a USB stick and is charged via USB ports. Nicotine cartridges or "pods" are available which are available in various flavors (including Mint, Mango, Royal Cream, Apple, Rich Tobacco) and which contain essentially glycerol, propylene glycol, natural oils, extracts and flavor, nicotine and benzoic acid. In this vaporizer, in comparison to previous ENDS, apart from the novel product design, the high nicotine concentration, in Germany at 1.7% nicotine (20 mg / ml), is even nicotine at 5% (59 mg / ml) lies. The nicotine concentration released on use should be similar to the tobacco cigarette. The higher nicotine concentration is due to the use of organic nicotine salts extracted from tobacco leaves instead of the "Freebase formulations" of nicotine used in other ENDS. The respiratory irritant effect, which results from very high nicotine doses, is reduced by the benzoic acid contained. Thus, higher doses of nicotine can be absorbed. So far it is still unclear whether the benzoic acid in addition to a reduction in irritation and the rate of inrush of nicotine in the organism can improve. Since the rate of drug inflow is strongly correlated with the dependency-inducing effect of a substance, this form of ENDS may be associated with high addictive potential.
That's exactly what we want to examine in our study. According to the study protocol, in the first 5 minutes of a standardized use of Juul, blood is to be taken off via a venous indwelling cannula and its concentration of nicotine determined at 5 measurement times. As a control, the same procedure is applied to smokers while smoking a conventional tobacco cigarette. The laboratory chemical analyzes are carried out by the colleagues of the Federal Institute for Risk Assessment, Max-Dohrn-Strasse 8-10 in 10589 Berlin. The study is complementary to our study published in 2017: "Nicotine delivery efficiency of first- and second-generation e-cigarettes and its impact on relief of craving during the acute phase of use" (T. Rüther et al International Journal of Hygiene and Environmental Health 2017).
With this study, we want to make a small contribution to the objective consideration of the product JUUL, in order to possibly be able to provide a risk assessment regarding the addictive potential, from which recommendations for action for users, patients and addiction therapists could be derived.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

After the completion of the recruitment phase and the subsequent evaluation, a publication of the results (including nicotine levels, EEG data, questionnaire results) is planned.

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Organizational Data

  •   DRKS00017432
  •   2019/06/06
  •   [---]*
  •   yes
  •   Approved
  •   72-15, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
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Interventions/Observational Groups

  •   E-Cigarette Juul Vaper.
    According to the study protocol, the first 5 minutes of a standardized use of the Juul blood should be taken and its concentration of nicotine should be determined at 5 measuring points. As a control, the same procedure is used for smokers while smoking a conventional tobacco cigarette. The laboratory chemical analyses are carried out by colleagues from the Federal Institute for Risk Assessment, Max-Dohrn-Strasse 8-10 in 10589 Berlin.
  •   Smoker tobacco cigarette
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Other
  •   Other
  •   Factorial
  •   IV
  •   N/A
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Primary Outcome

Assessment of the speed and concentration of nicotine infiltration of the E-cigarette JUUL compared to the conventional tobacco cigarette in the acute phase at 5 measurement times.

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Secondary Outcome

Assessment of the addictive potential, since drug infiltration and concentration strongly correlate with the addictive potential.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/01/08
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
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Additional Inclusion Criteria

Inclusion / exclusion criteria
General inclusion criteria:
• Subjects between 18 and 55 years
• 12-hour abstinence (both e-cigarette users and tobacco smokers)
• CO < 5ppm; Measurement in the expired air using micro-smokerlyzer (Bedfont Scientific Ltd.)
• capacity to consent
Special inclusion criteria for the electric cigarette users
• experienced e-cigarette user for > 3 months, daily consumption
• no consumption of conventional tobacco cigarettes for > 3 months
Special inclusion criteria for smokers
• Smoker for > 5 years daily > 10 cigarettes / day

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Exclusion Criteria

Exclusion criteria
• Patients under the age of 18 or over 55 years
• acute psychiatric disorders according to ICD-10 / DSM IV
• other serious psychiatric illnesses
• acute suicidality
• existing pregnancy
• Drug, drug or alcohol abuse at the time of the study
• current malignancies in the last 5 years
• severe internal diseases, especially cardiovascular diseases, such as
-- manifest arterial hypertension
-- severe heart disease (DCM, history of a heart attack)
-- pacemaker
-- respiratory failure
• severe active infectious diseases
• CO> 5 ppm in the expirium
• other circumstances that, in the investigator's opinion, militate against patient participation in this study

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie des Klinikums der Ludwigs-Maximilians Universität München
    • Ms.  Dr.  Andrea  Rabenstein 
    • Nußbaumstrasse 7
    • 80336  München
    • Germany
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    • Bundesinstituts für Risikobewertung
    • Mr.  Dr.  Frank  Henkler-Stephani 
    • Max-Dohrn-Strasse 8-10
    • 10589  Berlin
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie des Klinikums der Ludwig Maximilians Universität München
    • Ms.  Dr.  Andrea  Rabenstein 
    • Nußbaumstrasse 7
    • 80336  München
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinik für Psychiatrie und Psychotherapie des Klinikums der Ludwis-Maximilian Universität München
    • Ms.  Dr.  Andrea  Rabenstein 
    • Nußbaumstrasse 7
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und Psychotherapie des Klinikums der Ludwigs-Maximilians Universität München
    • Mr.  Dr.  Tobias  Rüther 
    • Nußbaumstrasse 7
    • 80336  München
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Bundesinstitut für Risikobewertung
    • Mr.  Dr.  Frank  Henkler-Stephanie 
    • Max-Dohrn-Strasse 8-10
    • 10589  Berlin
    • Germany
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    start of 1:1-Block address contact otherSupport
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.