Trial document




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  DRKS00005093

Trial Description

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Title

Spice II Plus: Acute toxicity of new synthetic cannabinoids and stimulant drugs

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Trial Acronym

Spice II Plus

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Since 2008, there has been an increase in the consumption of designer drugs. Two thirds of the substances that were newly recorded by the european early warning system were synthetic cannabinoids and synthetic cathinones. Whereas in the past many of this substances were placed under illicit-drugs-laws (lastly in July 2012), some new substances have still no legal regulation.
These seemingly harmless products may nevertheless lead to unexpected psychic and physical disorder causing the 'user' to seek emergency treatment.
In order to associate the reported symptoms to the consumed substances, an analytical verification of the uptake is required.
Trial objective:
To find out which new drugs lead to consultation of emergency units because of undesirable effects.
To correlate symptoms and outcome to the substances found in the toxicological analysis.
Toxicological assessment of the drug.
To identify the circumstances of consumption that possibly enhance toxicity.

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Brief Summary in Scientific Language

Since 2008, there has been an increase in the consumption of designer drugs. Two thirds of the substances that were newly recorded by the european early warning system were synthetic cannabinoids and synthetic cathinones. Whereas in the past many of this substances were placed under illicit-drugs-laws (lastly in July 2012), some new substances have still have no legal regulation.
These seemingly harmless products can therefore lead to unexpected psychic and physical disorder causing the 'user' to seek medical help in emergency units or consult a poison control center.
In order to associate the reported symptoms to the consumed substances, an analytical proof of the named substances is required.

Primary objective:
To find out which new drugs lead to consultation of poison control centers and emergency units because of undesirable effects.
To correlate symptoms and outcome to the substances found in the toxicological analysis.
Toxicological assessment of the drug.
To identify the circumstances of consumption that possibly enhance toxicity.

Secondary objective:
-To discover interaction with other drugs and medication.
- To improve the quality of emergeny treatment and of emergency consultation

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Organizational Data

  •   DRKS00005093
  •   2013/07/24
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  •   yes
  •   Approved
  •   235/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1145-4535 
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Health Condition or Problem studied

  •   Acute poisoning through new designer drugs
  •   T40.7 -  Poisoning: Cannabis (derivatives)
  •   T43.9 -  Poisoning: Psychotropic drug, unspecified
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Interventions/Observational Groups

  •   Two Parts:
    Part 1:
    Retrospective inquiry in the poison control center Freiburg database, regarding cases of human exposure to new designer drugs (cathinone derivatives and other drugs not listed in the PCC- Freiburg till 2007), as well as ‘Spice’ mixtures which lead to consultation of medical facilities and emergency units.
    Correlation of this pseudomised data with analytical data of the forensic department. The specified period is between 02/2011- 04/2013 for ‘Spice’ mixtures and between 01/01/2008 - 30/04/2013 for other designer drugs.

    Part 2:
    prospective survey of acute intoxications by new synthetic designer drugs and other (unknown) drugs especially synthetic cannbinoids, cathinone derivatives and research chemicals, that were not listed in the PCC databank till 2007

    Collected data

    Case number (pseudomised), Type of caller (hospital/emergency doctor, private practice), year of primary consultation, age (years), gender, weight, primary agent ( name of drug /chemical, dose (if known), other agents (substance, dose), time lapse, form and circumstances of exposure, mode (inhalative, oral), symptoms, outcome, recommended and performed diagnostics (including toxicological analysis), therapy ( duration of in- patient therapy in days) risks ( pre-existing conditions, other agents)- if known. Assessment of the Data and allocation of poisoning severity scores, PSS [Persson 1998]
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary objective:
To find out which new drugs lead to consultation of poison control centers and emergency units because of undesirable effects.
To correlate symptoms and outcome to the substances found in the toxicological analysis.
Toxicological assessment of the drug.
To identify the circumstances of consumption that possibly enhance toxicity.

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Secondary Outcome

Secondary objective:
-To discover interaction with other drugs and medication.
- To improve the quality of consultation during emergency

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/14
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

-Exposure to new synthetic Designer Drugs and other (unknown) drugs especially cathinone derivatives and Research chemicals that were not listed in the PCC Databank till 2007, as well as sythetic cannabinoids
- Consultation of a medical/emergency Unit
- Agreement to participation in Survey

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Exclusion Criteria

- Non-professional inquiry
- Disagreement to participation in Survey

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Addresses

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    • Vergiftungs-Informations-Zentrale, Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Vergiftungs-Informations-Zentrale
    • Ms.  Dr. med.  Maren  Hermanns-Clausen 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Vergiftungs-Informations-Zentrale
    • Ms.  Josephine  Kithinji 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • European Commission, Directorate-General for Research and Innovation
    • ORBN 2/65
    • B-1049  Brussels
    • Belgium
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    • Bundesministerium für Gesundheit (BMG)
    • Rochusstr. 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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