A Study to Evaluate the Safety of Acamprosate for Alcohol Use Disorder

Overview

About this study

The purpose of this study is to evaluate the safety of acamprosate in individuals with alcohol-use disorder (AUD) and alcohol-related liver disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).
  • 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 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507)284-2638

Olofson.Amy@mayo.edu

Mankato, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Contact us for the latest status

Contact information:

Cori Larson CCRP

(507) 255-0036

Larson.Cori@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478969

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