Patients with alcohol dependence in withdrawal states.
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age between 18 and 65 - knowledge of german language - alcohol dependence in DSM IV and ICD-10 - alcohol withdrawal syndrome in DSM IV and ICD-10 with AWSS-sum >=4 - negative drog screening for heroin, cocaine, benzodiazepine, methadone - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - beginning or present delirium tremens, but not delirium tremens in history - an additional dependence, except nicotine/caffeine - present seizure disorders, except alcohol withdrawal convulsions - history of brain injuries or other neurological diseases, except alcohol related neurological disorders, e.g. polyneuropathy - present continious medication with drugs that influence withdrawal symptoms (benzodiazepines, neuroleptics,anti-epileptic drugs, antihypertensive drugs) - contraindications or severe events for one of the following drugs: diazepam, pregabalin, clonidin, haloperidol - pregnancy, lactation,insufficient contraception - other psychiatric axis 1 diseases, except alcohol dependancy - acute suicidal tendency - severe internal diseases like pancreatitis, pneumonia, coronar heart disease, hypertension, gastro-intestinal bleeding - severe hepatic damage, severe renal lesion - participation in an other clinical trial during, either contemporaneous or during the last 4 weeks - compulsory admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): cumulative dosage of diazepam additionally to IMP;Main Objective: The main objektive of the trial is to examine the effectiveness and safety of pregabalin in treatment of alcohol-withdrawal. To determine this a lowered total cumulative consumption of diazepam as add-on shall be proved in inpatient alcoholics ethanol-withdrawal state treated with pregabalin compared to a placebo-treated group. ;Secondary Objective: Secondary objectives of the trial are to show : - a difference of the AWSS-Score and the CIWA-Score, during the 2nd day til the end of treatment between both groups - changes in alcohol-specific/ neurpsychological scales CGI, VAC, VASE, HAM-D and HAM-A - tolerance of the IMP, as meassured by spontaneus reported adverse effects - safety (number of hypertensiv crises, withdrawal convulsions, appearance of deririous symptoms, laboratory parameters, needed dose of comedications) - drop-out rate | — |
Countries
Germany
Outcome results
None listed