Trial document
DRKS00003357
Trial Description
Title
Dysfunctional neuronal networks in alcoholism: Utilizing translational neuroimaging to identify altered brain connectivity and treatment efficacy predictors
Trial Acronym
Transalc
URL of the Trial
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.
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.
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
Secondary IDs
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Health Condition or Problem studied
- F10.2 - Mental and behavioural disorders due to use of alcohol; Dependence syndrome
Interventions/Observational Groups
- alcohol dependent patients with anticraving medication (Naltrexone or Acamprosate)
- alcohol dependent patients without anticraving medication
- healthy controlls
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
Primary Outcome
To determine differences in functional connectivity between alcohol addicted patients and healthy controls using rsfMRI and DTI
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
Countries of Recruitment
- Germany
- Canada
Locations of Recruitment
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Recruitment
- Actual
- 2011/12/01
- 270
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- 75 Years
Additional Inclusion Criteria
alcohol dependence (DSM IV; ICD 10) and
average84g of pure alcohol per day during the last 90 days
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
Addresses
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start of 1:1-Block address primary-sponsor
- Zentralinstitut für Seelische Gesundheit
- Mr. Prof.Dr. Karl Mann
- J 5
- 68159 Mannheim
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0621 1703 3501
- 0621 1703 3505
- karl.mann at zi-mannheim.de
- http://www.zi-mannheim.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
- Mr. Dr. med. Derik Hermann
- J5
- 68199 Mannheim
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0621/17033541
- 0621/17033505
- derik.hermann at zi-mannheim.de
- http//:www.zi-mannheim.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
- Mr. Dr. med. Derik Hermann
- J 5
- 68159 Mannheim
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0621/17033541
- 0621/17033505
- derik.hermann at zi-mannheim.de
- http//:www.zi-mannheim.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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