Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients (Keppra-2)

Charité University Medicine Berlin

Status and phase

Completed

Phase 3

Conditions

Alcoholic Relapse

Alcohol Dependence

Treatments

Drug: Placebo

Drug: levetiracetam (Keppra)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00758277

Kep-F10.2.01

Details and patient eligibility

About

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

Full 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

Enrollment

201 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).