Ensayos clínicos

Inclusion Criteria:

• Aged 21 years or over,
• Diagnosis of alcohol-related liver disease and alcohol use disorder (AUD).
• The diagnosis of alcohol-related liver disease will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging and laboratory findings and typical histology on liver biopsy, if performed. Underlying liver disease may include alcoholic hepatitis, advanced (F3-F4) fibrosis, and/or portal hypertension.
• The diagnosis of AUD will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with DSM-5 diagnostic criteria for AUD (all categories of mild, moderate and severe considered eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).
• At study enrollment, initial MELD-Na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. The second phase of the pilot safety assessment will include individuals with a MELD-Na of 20 increase by more than than 5 points from baseline or doubling bilirubin level from enrollment, the DSMB will review the records to determine whether DILI is suspected or changes are attributed to natural course of disease.
• Have capacity to provide consent themselves.

Exclusion Criteria:

• Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min.
• Congestive heart failure (NYHA class II or higher)
• Hypotension, requiring the use of vasoconstrictors (i.e., midodrine).
• Pregnancy, lactation or refusal to use a reliable method of birth control if a sexually active female of childbearing potential. Although no human trial data is available, animal studies suggest possible teratogenic effects of acamprosate (Merck, 2005).

Eligibility last updated 5/17/22. Questions regarding updates should be directed to the study team contact.