Acamprosate Safe to Use in Individuals With Liver Disease.

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Alcohol-related Liver Disease

Treatments: Drug: Acomprosate

Study type: Interventional

Funder types: Other

Identifiers

NCT04287920

18-010902

Details and patient eligibility

About

Is acamprosate safe to use in individuals with liver disease.

Full description

Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.

Enrollment: 12 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 21 or over

• Diagnosis of alcohol-related liver disease and 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).

• Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.

• 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 or more at enrollment.

• 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Alcohol-related liver disease and AUD, MELD-NA less than 20

Experimental group

Description:

The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.

Treatment:

Drug: Acomprosate

Alcohol-related liver disease and AUD, MELD-NA more than 20

Experimental group

Description:

The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.

Treatment:

Drug: Acomprosate