Status:
COMPLETED
Acamprosate Safe to Use in Individuals With Liver Disease.
Lead Sponsor:
Mayo Clinic
Conditions:
Alcohol-related Liver Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Is acamprosate safe to use in individuals with liver disease.
Detailed 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 in...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04287920
Start Date
September 21 2020
End Date
January 5 2022
Last Update
December 20 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905