Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse. Secondary objective size are: * Frequency of Lapses * Time up to the first alcohol drinking * cumulative times of do not drink * Craving * Alcohol drinking quantity * Sleep quality * Tolerability/Bearableness of the study medication * Security * Drop Out rate * Side effects * Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB, SCL-90. * Quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
201
levetiracetam daily application 1500-2000 mg
Sugar Pill
Klinikum Nürnberg Nord
Nuremberg, Bavaria, Germany
Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
Bochum, North Rhine-Westphalia, Germany
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Time frame: During and after treatment
1 Time up to first drinking
Time frame: During treatment
2 cumulative Time of do not drinking over the study duration
Time frame: during treatment
3 Frequency of Lapses
Time frame: during treatment
Tolerability of the study medication
Time frame: during treatment
Drop Out rate
Time frame: during treatment
Side effects
Time frame: during treatment
Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
Time frame: during treatment
Quality of life
Time frame: during treatment
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