Acamprosate Safe to Use in Individuals With Liver Disease.

Alcohol-related Liver Disease Clinical Trial

Official title:

A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287920
• Other study ID #: 18-010902
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2020
• Est. completion date: January 5, 2022

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Is acamprosate safe to use in individuals with liver disease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol-related Liver Disease
• Liver Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event	Number of adverse events reported	24 weeks
Secondary	Change in Alcohol Craving	Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom.	Baseline, week 24

External Links

•   Mayo Clinic Clinical Trials