Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence

Inclusion Criteria: * Signed and dated informed consent. * Outpatients (not hospitalized by the moment of randomization). * Average alcohol consumption during 30 days prior to screening higher than a medium drinking risk level (men: \> 4 drinks/day or 14 drinks/week; women \> 3 drinks/day or 7 drinks/week) according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria. * Patients diagnosed with alcohol dependence according to the International Classification of Diseases (ICD)-10, assessed with the Mini-International Neuropsychiatric Interview (MINI). * Abstaining from alcohol during 3 days prior to screening and 3 days before randomization confirmed by the test for alcohol in exhaled air (less than 0,02 %). * For women retaining childbearing potential - negative pregnancy test and consent to use reliable contraception methods (as well as for men) throughout the study period, including the study follow up period. * Patients able to comply with study protocol as per investigator's opinion. * Availability of a patient's trustee who reside with the patient. A trustee is defined here as a person who spends with the patient at least 4 hours a day. The trustee must give his/her consent for participation in the study as the patient's representative. * Study drug monotherapy must be acceptable for the patient as per investigator's opinion. Exclusion Criteria: * Hypersensitivity to Odelepran or to any excipient of the study drug (including lactose intolerance). * Binge drinking (more than 5 day consecutive days of heavy drinking) during 30 days prior to screening. Heavy drinking is considered as 5 or more drinks per day for men and 4 or more drinks per day for women. * Ever diagnosed schizophrenia, schizoaffective disorder, bipolar mood disorder or any other psychiatric disorder, except for alcohol dependence. History of alcohol induced psychosis. * Anxiety or depressive disorder present at enrollment into the study. Montgomery-Asberg Depression Rating Scale (MADRS) score higher than 15. * High suicidal risk confirmed by MINI. * Previous use of opioid antagonists implants less than 3 months prior to screening; use of long-acting naltrexone injections (e,g, Vivitrol) less than 4 weeks after the first injection and 3 months after the second and the following injections; use of cyanamide (Kolme) less than 2 weeks prior to screening, use of oral opioid antagonists or disulfiram during 2 weeks prior to screening. * Psychotherapeutic "coding" (a method when the patient is induced a misbelief that alcohol consumption would lead to death, expected to result from undisclosed pharmacological manipulation) that took place during less than 3 months prior to screening. * Use of psychotropic medication less than 3 weeks before the screening (for long-acting and 'depot' formulations) or 1 week before the screening (for other formulations) except for those used to treat alcohol withdrawal syndrome. * Severe alcohol withdrawal syndrome (severity of alcohol withdrawal more than 10 on Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale). * History of seizures (excepting febrile seizers). Severe brain injury, history of intracranial neoplasms and/or intracranial haemorrhages or any conditions that impose the risk of seizures. History of anticonvulsive therapy. * Any clinical condition affecting cognitive or other psychoneurological functioning (verified for head injury with the loss of consciousness that lasted more than 1 hour, or resulted in cognitive or behavioral impairment, stroke, encephalopathy, dementia, neurodegenerative disorder, etc). Except for mild cognitive impairment. * Mental retardation of syndromes of severe organic brain injury. * Use of drugs of abuse (opioids, cannabinoids, amphetamines, etc.) or diagnoses of substance addiction/dependence at the moment of screening or positive urine drug screen test. * Significant liver function impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) higher than 3 upper limits of normal range or diagnosis of hepatic failure, class B or C by Child Pugh). * Severe renal failure (creatinine clearance calculated at the screening less than 30 ml/min or renal replacement therapy). * Severe cardiovascular system disorders: unstable angina, poorly controlled arrhythmia, cardiac failure of III or IV class by New-York Heart Association (NYHA), acute myocardial infarction within the past 6 months. * HIV-infection, hepatitis B or C. * Decompensated diabetes mellitus (determined glycated hemoglobin HbAc1 level more than 7,5%) * Other concomitant disorders and conditions that, as per investigator's opinion, put the patient's safety under risk or that could affect the analysis of safety data. * Any diagnosed or suspected malignancy. * Pregnancy, breast feeding. * Participation in any other clinical study during 30 days or 6 periods of half life (depending on what is longer) prior to screening. * Patients that need treatment with drugs prohibited by the study protocol (opioid antagonists, psychotropic medications, opioid analgesics, anticonvulsants, central muscle relaxants, antineoplastic drugs, glucocorticoids).