Efficacy and safety of levetiracetam in prevention of alcohol relapse in recently detoxified alcohol dependent patients - Keppra 2

Phase 1

• Conditions: detoxified alcohol dependent outpatients

• Registration Number: EUCTR2006-003999-35-DE
• Lead Sponsor: Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-10
• Study Completion: 2009-12-31
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

ages eligible for study 18-70 years
meets criteria for alcohol dependence according to DSM-IV/ICD-10
detoxified alcohol dependent patients
able to provide a written informed consent
able to follow verbal and written instruction (incl. sufficient knowledge of German language)av
have a negative urine drug screen for benzodiazepines and opiates
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

alcohol withdrawal syndrome beginning or existing • Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps
•Specific ones behavior or tiefenpsychologsiche single therapy or manual-led group therapies parallel to the clinical study
• any further substance dependence except nicotine- and/or coffeinedependence. A Substanzabusus according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.
• Ideopathi epilepsy, not however admitted alcohol withdrawal convulsions
• Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. polyneuropathia
• current co-medication by means of medicines, which can affect significantly withdrawal symptoms or craving or promote the abstinence,e.g. benzodiazepines, antiepileptics, neuroleptics,
• Contraindications or heavy side effects in relation to the study medication, or hypersensitivity opposite Pyrrolidonderivate
• Pregnancy or quiet time or insufficient contrazeption
• Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
• Acute suizidality, not convincingly arrangementable
• Weight internal illnesses, e.g. pankreatite, pneumonia, cardiac infarct, gastrointerstinale bleedings etc.)
• Weight kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers)
• Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: investigate in the efficacy and safety of levetiracetam versus placebo to prevent relapse in alcohol dependency;Secondary Objective: craving, drop-out-rate, sleeping quality, frequence of lapses, time to first drinking, life quality, changing in HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, SCL-90.;Primary end point(s): With the occurrence one of the exclusion criteria and/or with a heavy relapse, defines for men: at least 5 standard drinks, for women: at least 4 standard drinks over 2 days and/or easy