Alcohol addiction
Conditions
Interventions
Trade Name: ALCOVER
Product Name: ALCOVER
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Sponsors
LABORATORIO FARMACEUTICO CT SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signature of Informed Consent for the study and for treatment of personal data (before each study related procedure) 2. Male or female of any ethnic group between 18- and 65-years old 3. Body weight between 60 and 100 kg with a BMI 60 g / day in males and> 40 g / day in females; VHDRL:> 100 g / day in males and> 60 g / day in females) 6. No or mild alcohol withdrawal symptoms, defined as CIWA-Ar score 15) 12. Females only: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry, throughout the study, and for two months after the end of treatment***. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous use of Sodium Oxybate 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 cannabinoids, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary The primary objective of the present study is to demonstrate the efficacy of Sodium Oxybate in reducing the alcohol consumption, in the population of alcoholdependent with High or Very High Drinking Risk Level (HDRL and VHDRL), as measured by the number of HDDs.;Secondary Objective: Secondary Secondary objectives include the demonstration of the efficacy of Sodium Oxybate in: - maintaining the abstinence: - increasing the proportion of subjects showing a reduction in HDDs - reducing monthly alcohol consumption - reducing alcohol craving - alcohol biomarkers normalization - improving clinical global condition - improving subjects’ quality of life - improving subjects’ global impression Finally, secondary objectives include additional data collection and explorative secondary endpoints also in: - the safe use of Alcover in subjects with mild/moderate liver diseases - the evaluation of protracted alcohol withdrawal syndrome, assessing the necessity of a prolonged treatment (beyond 2 weeks) for an adequate control of the related typical symptoms. ;Primary end point(s): The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12). ;Timepoint(s) of evaluation of this end point: Visit 7, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - % of Subjects with continuous abstinence rate in the 4 weeks preceding the last visit (V7, week 12). - % of Subjects who achieved at least 30% days of abstinent days (PAD) during the 12 weeks of treatment. - % of Subjects who have reduced by at least 30, 50 and 70% the number of HDDs. - Reduction of total alcohol consumption (TAC) expressed in g / die per month - % of Subjects achieving at least the 30% reduction in craving for alcohol - % of Subjects with normal alcohol biomarkers at the end of treatment (MCV, ?-GT, ALT, AST, CDT). - % of Subjects with improvement of psychopathological parameters and relational, functional and psychosocial aspects. Safety - % of adverse effects and their characteristics - % of Subjects with medication misuse and/or abuse - % of Subjects experiencing medication craving - % of Subjects experiencing symptoms and/or signs of abstinence when treatment is discontinued (follow-up evaluation, V8, week 24). - % of Subjects experiencing symptoms and/or signs of protracted withdrawal syndrome (AWS) compared to baseline, during the treatment and at V7 and V8. - % of Subjects requiring additional treatments to control the protracted withdrawal syndrome symptoms. Quality of Life Quality of life improvement measured trough SF 36 questionnaire score compared to baseline. ;Timepoint(s) of evaluation of this end point: V1, V4, V5, V6, V7, V8 | — |
Countries
Italy
Contacts
Public ContactDipartamento di Ricerca Clinica
GB PHARMA SERVICES & CONSULTING SRL
Outcome results
None listed