Trial document




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  DRKS00003357

Trial Description

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Title

Dysfunctional neuronal networks in alcoholism: Utilizing translational neuroimaging to identify altered brain connectivity and treatment efficacy predictors

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Trial Acronym

Transalc

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URL of the Trial

http://www.transalc.eu

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Brief Summary in Lay Language

There is some evidence that the connections between different brain areas are affected by alcohol dependence. Therefore we want to investigate the differences between alchol- dependet patientes and healthy controll subjects.
With MRI (Magnet Resonance Imaging) we will make brain images using two different techniques: First Diffusions-Tensor-Imaging (DTI) to see how well and in which direction the water inclosed in the neuronal brain bundles moves. This shows whether the function of the brain bundles and the flow of information between brain areas is efficient. Second we will make a Resting-State MRI. This is to investigate the communication of brain areas without doing concentrated exercises but beeing at rest. If two areas show activity at the same time we can conclude that they have a connection.


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Brief Summary in Scientific Language

Alcoholism is a common psychiatric disorder with largely unmet treatment needs. Excellent animal models for this disorder have put forward a number of promising molecular targets for medication development. Yet, clinical trials aimed at exploiting this potential often fall short of expectations. We aim to improve the predictive validity of animal tests by means of functional connectivity analysis using magnetic resonance imaging (MRI) to identify brain response patterns to pharmacotherapy that are comparable between patients and animal models of alcoholism. To this end we have formed an international consortium with highly complementary expertise in the field of alcoholism and neuroimaging research. This project will reveal alcoholism specific connectivity maps and knowledge of their modification by clinical reference compounds, i.e. acamprosate and naltrexone, in humans and animals. Based on this information we expect to predict better the effects of experimental drugs proposed for treatment of alcoholism in human patients.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003357
  •   2011/11/29
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  •   yes
  •   Approved
  •   2010-348N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   alcohol dependent patients with anticraving medication (Naltrexone or Acamprosate)
  •   alcohol dependent patients without anticraving medication
  •   healthy controlls
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

To determine differences in functional connectivity between alcohol addicted patients and healthy controls using rsfMRI and DTI

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Secondary Outcome

To determine differences in functional connectivity between alcohol addicted patients treated with Naltrexone or Acamprosate vs. alcohol addicted patients without medication using rsfMRI and DTI

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Countries of Recruitment

  •   Germany
  •   Canada
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/12/01
  •   270
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

alcohol dependence (DSM IV; ICD 10) and
average84g of pure alcohol per day during the last 90 days

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Exclusion Criteria

other Axis 1 psychiatric diagnoses than alcohol- or nicotine-dependence in the last 12 months, common exclusion criteria for MRI, positive urine drug screen, severe medical illness and history of brain injury

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Addresses

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof.Dr.  Karl  Mann 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Dr. med.  Derik  Hermann 
    • J5
    • 68199  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Dr. med.  Derik   Hermann 
    • J 5
    • 68159   Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Friedrichstraße 130 B
    • 10117   Berlin
    • Germany
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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.