Phase
Condition
Substance Abuse
Addictions
Alcohol Use Disorder
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 18 and not older than 70 years
Good knowledge of the German language
The criteria of an alcohol dependence after DSM IV and ICD 10 fulfill
To the recruiting time alkoholabstinently living, i.e. after successful alcoholdecontamination, the patients must have understood the meaning and consequence of thestudy and have delivered before beginning of study your written agreement to theparticipation.
Negative drug screening regarding Benzodiazepines and Opiates.
With Females either o at least 1 year Menopause or after Sterilization orcontraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormoneplaster, hormone spiral at least 1 month before study inclusion or use of the doublebarrier method with Spermiziddiaphragma plus condom use or renouncement of sexualintercourse during the entire study duration and resolution a pregnancy to avoid withnegative β-HCG-test
Exclusion
Exclusion Criteria:
Alcohol withdrawal syndrome beginning or existing
Simultaneous one ambulatory or stationary curing therapy, not however participation ingroups of self-helps
Specific ones behavior or deep-psychological single therapy or manual-led grouptherapies parallel to the clinical study
Any further substance dependence except nicotine and/or Caffeine dependence A abuseaccording to the criteria of DSM-IV and/or ICD-10 is not considered as exclusionreason.
Idiopathic epilepsy, not however admitted alcohol withdrawal convulsions
Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not howeveralcohol-associated neurological disturbances, e.g. Polyneuropathie
current CO-medication by means of medicines, which can affect significantly withdrawalsymptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics,antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparableeffect mechanism) or Acamprosat, Disulfiram, or further substances, which can affectglutamaterge, dopaminerge, cholinergic, serotonerge or opiode system the GABAerge,
Contraindications or heavy side effects in relation to the study medication,hypersensitivity opposite Pyrrolidonderivate
Pregnancy or quiet time or insufficient Contraception
Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
Acute Suizidalität, not convincingly arrangementable
Severe internal illnesses, e.g. Pancreatitis, pneumonia, cardiac infarct,gastrointestinal bleedings etc.)
Severe kidney damage (starting from dekompensierter retention - stage 3 after thatnational Kidney Foundation) or heavy liver damage (starting from Child A after ChildPugh Score with living ore erring trousers) and/or creatinin Clearance of small 30ml/min
Simultaneous participation or within the last 4 weeks at another clinical study,however does not exist an exclusion with previous participation in the decontaminationstudy with Keppra ® (Keppra 1).
Study Design
Study Description
Connect with a study center
Klinikum Nürnberg Nord
Nürnberg, Bayern 90419
GermanySite Not Available
Klinikum Nürnberg Nord
Nürnberg, Bayern 90419
GermanySite Not Available
Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
Bochum, NRW 44791
GermanySite Not Available
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, NRW 53105
GermanySite Not Available
Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
Essen, NRW 45136
GermanySite Not Available
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
Essen, NRW 45147
GermanySite Not Available
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
Essen, NRW 45147
GermanySite Not Available
Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
Halle, Sachsen-Anhalt 06097
GermanySite Not Available
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Berlin, 10117
GermanySite Not Available
Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Berlin, 13347
GermanySite Not Available
PUK Charité im SHK
Berlin, 10559
GermanySite Not Available
Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
Berlin, 12099
GermanySite Not Available
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