Skuteczność i bezpieczeństwo stosowania Sodium Oxybate w zmniejszaniu spożycia alkoholu i utrzymywaniu abstynencji u osób o wysokim ryzyku spożywania nadmiernych ilości alkoholu w związku z chorobą alkoholową

Kryteria wyłączenia kto nie może wziąć udziału (1)

1. A Subject who met at least one of the following conditions is not eligible and should not be addressed to randomization and treatment phase: 1. Use of Sodium Oxybate during the three months prior to randomitation 2. Current diagnosis of substance dependence other than alcohol and nicotine 3. Lifetime diagnosis of schizophrenia, bipolar disorders, or other psychoses; lifetime diagnosis of Major Depression and history of attempted suicide. 4. History of epilepsy or alcohol-related seizures 5. Positive urine test for cocaine, opiates, methadone at any time during the study. 6. Current participation to another study or participation to an interventional study conducted during 3 months prior to randomization. 7. Females only: breast-feeding and/or positive urine pregnancy test at any time during the study. 8. Severe diseases and/or medical conditions, both acute and chronic, which in the opinion of the investigator jeopardize patient safety, including respiratory depression, liver diseases (e.g. acute hepatitis), decompensated cirrhosis. 9. Presence of particular social condition that, at the investigator judgement, may interfere with the proper study conduct (i.e. subject social marginalisation, Homeless condition, known history of previous crimes related to sexual abuse, drug dealing, etc) 10. Patients with porphyria 11. History of current epileptic syndrome with the exception of neonate convulsions. Patients with epileptic episodes due to alcohol withdrawal are also excluded 12. Known medical history of succinic semialdehyde dehydrogenase deficiency 13. Any significant cerebral vascular and/or cardiovascular disease (e.g., unstable angina pectoris at rest or for minimal effort, acute myocardial infarction within the last 3 months, hearth failure NYHA class II-IV) 14. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately (for instance Alzheimer’s disease and any other dementia) 15. Concomitant use of psychotropic medications including antiepileptic agents that cannot be discontinued; any medication that may have an effect on alcohol consumption, including baclofen, naltrexone, acamprosate, nalmefene, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, opioid analgesics, dopamine/norephinefrine reuptake inhibitors. 16. Subjects requiring a structured psychotherapy 17. Hypersensitivity to the active substance or to any of the excipients. 18. Female subjects not willing to undergo to an adequate contraception method for the study duration.