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

NCT ID: NCT00758277

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-12-31

Brief Summary

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

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, SCL-90.
• Quality of life

Conditions

Alcohol Dependence; Alcoholic Relapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Levetiracetam

Group Type: ACTIVE_COMPARATOR

levetiracetam (Keppra)

Intervention Type: DRUG

levetiracetam daily application 1500-2000 mg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar Pill

Interventions

levetiracetam (Keppra)

levetiracetam daily application 1500-2000 mg

Intervention Type: DRUG

Placebo

Sugar Pill

Intervention Type: DRUG

Other Intervention Names

KEPPRA

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charite University, Berlin, Germany

Principal Investigators

Martin Schaefer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany

Locations

Klinikum Nürnberg Nord

Nuremberg, Bavaria, Germany

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

Bochum, North Rhine-Westphalia, Germany

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, Germany

Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte

Essen, North Rhine-Westphalia, Germany

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

Essen, North Rhine-Westphalia, Germany

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

Essen, North Rhine-Westphalia, Germany

Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle

Halle, Saxony-Anhalt, Germany

Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

Berlin, State of Berlin, Germany

PUK Charité im SHK

Berlin, State of Berlin, Germany

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

Berlin, State of Berlin, Germany

Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin

Berlin, State of Berlin, Germany

Countries

Germany

References

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. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available.

Reference Type: BACKGROUND

PMID: 16702910 (View on PubMed)

Richter C, Effenberger S, Bschor T, Bonnet U, Haasen C, Preuss UW, Heinz A, Forg A, Volkmar K, Glauner T, Schaefer M. Efficacy and safety of levetiracetam for the prevention of alcohol relapse in recently detoxified alcohol-dependent patients: a randomized trial. J Clin Psychopharmacol. 2012 Aug;32(4):558-62. doi: 10.1097/JCP.0b013e31825e213e.

Reference Type: DERIVED

PMID: 22722516 (View on PubMed)

Other Identifiers

Kep-F10.2.01

Identifier Type: -

Identifier Source: org_study_id