Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial.

Abstract

To investigate the safety of acamprosate, a Food and Drug Administration-approved medication for alcohol use disorder, in patients with alcohol-associated liver disease. In this phase 2 open-label study, 12 patients with alcohol use disorder and alcohol-associated liver disease were enrolled between September 2020 and May 2022. Participants received acamprosate for 12 weeks and were followed up to 24 weeks. The primary end point was drug safety profile; secondary end points included alcohol craving, measured by the Penn Alcohol Craving Scale, and relapse. All safety data were reviewed by the Data and Safety Monitoring Board. Patients were enrolled sequentially with Model for End-Stage Liver Disease-Sodium score below 20 (n=6) and 20 and above (n=6). Median age was 50 years, and 7 (58.3%) were female. Seven patients confirmed initiation of acamprosate, whereas 5 were lost to follow-up. There were no significant adverse events; only 1 patient reported pruritus, and no patients demonstrated worsening of liver disease. All patients experienced a decrease in or unchanged craving score from baseline to end of study. Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy of acamprosate. ClinicalTrials.gov identifier: NCT04287920.