Clinical trial NCT00758277: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Official title: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Alcoholic Relapse
Keywords: prevention of alcohol relapse
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2008-09-25
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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).

Primary outcomes:
measure: Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
timeFrame: During and after treatment
Secondary outcomes:
measure: 1 Time up to first drinking
timeFrame: During treatment
measure: 2 cumulative Time of do not drinking over the study duration
timeFrame: during treatment
measure: 3 Frequency of Lapses
timeFrame: during treatment
measure: Tolerability of the study medication
timeFrame: during treatment
measure: Drop Out rate
timeFrame: during treatment
measure: Side effects
timeFrame: during treatment
measure: Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
timeFrame: during treatment
measure: Quality of life
timeFrame: during treatment
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
state: Bayern
city: Bochum
country: Germany
facility: Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
state: NRW
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie
state: NRW
city: Essen
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
state: NRW
city: Essen
country: Germany
facility: Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
state: NRW
city: Essen
country: Germany
facility: Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
state: NRW
city: Halle
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
city: Berlin
country: Germany
facility: PUK Charité im SHK
city: Berlin
country: Germany
facility: Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
city: Berlin
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Study officials:
affiliation: Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany
name: Martin Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.