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

Last updated: June 22, 2011
Sponsor: Charite University, Berlin, Germany
Overall Status: Completed

Phase

3

Condition

Substance Abuse

Addictions

Alcohol Use Disorder

Treatment

N/A

Clinical Study ID

NCT00758277
Kep-F10.2.01
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 alcoholdecontamination, the patients must have understood the meaning and consequence of thestudy and have delivered before beginning of study your written agreement to theparticipation.

  • Negative drug screening regarding Benzodiazepines and Opiates.

  • With Females either o at least 1 year Menopause or after Sterilization orcontraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormoneplaster, hormone spiral at least 1 month before study inclusion or use of the doublebarrier method with Spermiziddiaphragma plus condom use or renouncement of sexualintercourse during the entire study duration and resolution a pregnancy to avoid withnegative β-HCG-test

Exclusion

Exclusion Criteria:

  • Alcohol withdrawal syndrome beginning or existing

  • Simultaneous one ambulatory or stationary curing therapy, not however participation ingroups of self-helps

  • Specific ones behavior or deep-psychological single therapy or manual-led grouptherapies parallel to the clinical study

  • Any further substance dependence except nicotine and/or Caffeine dependence A abuseaccording to the criteria of DSM-IV and/or ICD-10 is not considered as exclusionreason.

  • Idiopathic epilepsy, not however admitted alcohol withdrawal convulsions

  • Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not howeveralcohol-associated neurological disturbances, e.g. Polyneuropathie

  • current CO-medication by means of medicines, which can affect significantly withdrawalsymptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics,antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparableeffect mechanism) or Acamprosat, Disulfiram, or further substances, which can affectglutamaterge, 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 thatnational Kidney Foundation) or heavy liver damage (starting from Child A after ChildPugh 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 decontaminationstudy with Keppra ® (Keppra 1).

Study Design

Total Participants: 201
Study Start date:
May 01, 2007
Estimated Completion Date:
December 31, 2009

Study 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

Connect with a study center

  • Klinikum Nürnberg Nord

    Nürnberg, Bayern 90419
    Germany

    Site Not Available

  • Klinikum Nürnberg Nord

    Nürnberg, Bayern 90419
    Germany

    Site Not Available

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

    Bochum, NRW 44791
    Germany

    Site Not Available

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Bonn, NRW 53105
    Germany

    Site Not Available

  • Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte

    Essen, NRW 45136
    Germany

    Site Not Available

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

    Essen, NRW 45147
    Germany

    Site Not Available

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

    Essen, NRW 45147
    Germany

    Site Not Available

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

    Halle, Sachsen-Anhalt 06097
    Germany

    Site Not Available

  • Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

    Berlin, 10117
    Germany

    Site Not Available

  • Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin

    Berlin, 13347
    Germany

    Site Not Available

  • PUK Charité im SHK

    Berlin, 10559
    Germany

    Site Not Available

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

    Berlin, 12099
    Germany

    Site Not Available

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