Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

Exclusion Criteria

• •cirrhosis Child Pugh C (decompensated cirrhosis)
• •cirrhosis complicated by hepatocellular carcinoma or type I or II hepatorenal syndrome or poorly controlled portal hypertension,
• •severe acute alcoholic hepatitis, not responding to corticosteroids by the 7th day defined by a Lille model \> 0.56 (www.lillemodel.com/score.asp)
• •hepatic encephalopathy during the 6 months preceding the screening visit,
• •patient with fewer than 6 heavy drinking days during the 4 weeks preceding the screening visit (a heavy drinking day is defined as alcohol consumption of ≥ 60 g/day for men, and ≥ 40 g/day for women),
• •patient with at least 14 consecutive days of abstinence during the 4 weeks preceding the screening visit,
• •patient with a CIWA-Ar score (Revised Clinical Institute Withdrawal Assessment for Alcohol) ≥ 10,
• •patient with:
• •a disorder other than alcohol or nicotine dependence, as evaluated on the MINI (Mini-International Neuropsychiatric Interview)
• •antisocial personality disorder evaluated with the MINI questionnaire,
• •other disorders for which treatment must take priority to the treatment of alcohol dependence, or which are likely to interfere with the study treatment or compromise adherence to treatment,
• •cannabis use does not constitute an exclusion criterion except when it meets the criterion of cannabis dependence
• •patient with a suicide risk evaluated using the suicidal tendency module of the MINI (the patient answers "Yes" to one of questions C2, C3, C4, C5 or C6 of the questionnaire),
• •patient with a history of delirium tremens or alcohol withdrawal seizures,
• •ongoing use of addictive substances other than cannabis, nicotine or benzodiazepines,
• •presence of a disorder of comprehension, mental retardation or encephalopathy,
• •presence of clinically significant unstable disease (e.g.: renal failure, cardiovascular, pulmonary, gastrointestinal, gastrointestinal, endocrine, neurological, infectious, neoplastic disease or metabolic disorders,
• •clinically significant ECG abnormalities,
• •history of serious drug allergy or hypersensitivity to nalmefene,
• •ongoing or recent treatment (during the 3 months preceding the screening visit) with disulfiram, acamprosate, topiramate, naltrexone, carbimide, or opioid antagonists,
• •ongoing or recent treatment (1 week preceding the screening visit) with opioid agonists or partial agonists,
• •ongoing or recent treatment (8 weeks preceding the screening visit) with antipsychotics or antidepressants,
• •patient taking or who has taken concomitant medications (see supplementary table),
• •patient with another disease or taking medications, which, in the investigator's opinion, could interfere with evaluations of safety, tolerability and efficacy,
• •treatment with an investigational medicinal product during the 30 days preceding the screening visit,
• •ongoing or recent participation (during the 4 weeks preceding the screening visit) in a drinking disorders treatment or support programme, including Alcoholics Anonymous, disintoxication treatment and treatment of alcohol withdrawal symptoms,
• •pregnancy or breastfeeding,
• •patient who, in the investigator's opinion, has little chance of complying with the protocol or unsuitable for the study for any other reason,
• •patient who has already participated in a clinical trial on nalmefene.