Acamprosate Safe to Use in Individuals With Liver Disease.
NCT ID: NCT04287920
Last Updated: 2022-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2020-09-21
2022-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Alcohol-related liver disease and AUD, MELD-NA less than 20
The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.
Acomprosate
Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
Alcohol-related liver disease and AUD, MELD-NA more than 20
The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.
Acomprosate
Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
Interventions
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Acomprosate
Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
21 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Douglas (Doug) A. Simonetto
Principal Investigator
Principal Investigators
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Douglas A Simonetto
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Wu T, Mousa OY, Kulai T, Larson C, Olofson A, Kamath PS, Shah VH, Taner T, Sanchez W, Simonetto DA. Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial. Mayo Clin Proc. 2025 Jun;100(6):954-961. doi: 10.1016/j.mayocp.2024.12.013. Epub 2025 Mar 26.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-010902
Identifier Type: -
Identifier Source: org_study_id