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Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Alcoholic Relapse

Intervention: levetiracetam (Keppra) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Martin Schaefer, MD, Principal Investigator, Affiliation: Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany


Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.

Clinical Details

Official title: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos

Secondary outcome:

1 Time up to first drinking

2 cumulative Time of do not drinking over the study duration

3 Frequency of Lapses

Tolerability of the study medication

Drop Out rate

Side effects

Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90

Quality of life

Detailed description: 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,


- Quality of life


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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 alcohol

decontamination, the patients must have understood the meaning and consequence of the study and have delivered before beginning of study your written agreement to the participation.

- Negative drug screening regarding Benzodiazepines and Opiates.

- With Females either o at least 1 year Menopause or after Sterilization or

contraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormone plaster, hormone spiral at least 1 month before study inclusion or use of the double barrier method with Spermiziddiaphragma plus condom use or renouncement of sexual intercourse during the entire study duration and resolution a pregnancy to avoid with negative β-HCG-test 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 deep-psychological single therapy or manual-led group

therapies parallel to the clinical study

- Any further substance dependence except nicotine and/or Caffeine dependence A abuse

according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.

- Idiopathic 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. Polyneuropathie

- current CO-medication by means of medicines, which can affect significantly

withdrawal symptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics, antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparable effect mechanism) or Acamprosat, Disulfiram, or further substances, which can affect glutamaterge, 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 that

national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh 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 decontamination study with Keppra ® (Keppra 1).

Locations and Contacts

Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie, Berlin 10117, Germany

Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin, Berlin 13347, Germany

PUK Charité im SHK, Berlin 10559, Germany

Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik, Berlin 12099, Germany

Klinikum Nürnberg Nord, Nürnberg, Bayern 90419, Germany

Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität, Bochum, NRW 44791, Germany

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Bonn, NRW 53105, Germany

Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen, Essen, NRW 45147, Germany

Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen, Essen, NRW 45147, Germany

Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte, Essen, NRW 45136, Germany

Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle, Halle, Sachsen-Anhalt 06097, Germany

Additional Information

Related publications:

Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9.

Starting date: May 2007
Last updated: June 22, 2011

Page last updated: August 23, 2015

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