Acamprosate Safe to Use in Individuals With Liver Disease.

NCT04287920 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-010902
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Is acamprosate safe to use in individuals with liver disease.

Conditions

Alcohol-related Liver Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Number of adverse events reported

  24 weeks

Secondary Outcomes (1)

• Change in Alcohol Craving

  Baseline, week 24

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Acomprosate

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

EXPERIMENTAL

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

Drug: Acomprosate

Interventions

Acomprosate DRUG

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 40136257 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Douglas (Doug) A. Simonetto, M.D.
• Organization: Mayo Clinic

Simonetto.Douglas@mayo.edu

507-284-4824

Study Officials

• Douglas A Simonetto

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 27, 2020
• Study Start: September 21, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)