A digital pill system to measure and support acamprosate adherence in individuals with alcohol associated liver disease

Abstract Alcohol use disorder (AUD) is a devastating disease with significant morbidity and mortality, particularly due to alcohol-associated liver disease (ALD). Early intervention and optimal medication adherence to medications for AUD (MAUD) can decrease alcohol use and prevent the progression of liver damage. Yet, adherence to MAUD, especially acamprosate - the preferred medication for AUD in individuals with ALD - remains suboptimal. This K23 proposal seeks to leverage an innovative digital pill system (DPS) that directly measures acamprosate ingestion and pairs it with a cognitive behavioral therapy (CBT)-based intervention. The DPS will collect real-time adherence data to contextualize and personalize smartphone-delivered adherence support, potentially revolutionizing how adherence is managed in high-risk AUD populations. To achieve this goal, we will 1) develop a user-centered adherence intervention paired with a DPS (AcamproSync) to informed tailored support for participants with ALD and AUD taking acamprosate; 2) test the feasibility and acceptability of AcamproSync through a pilot randomized controlled trial in N=50 individuals with AUD and ALD prescribed acamprosate compared to treatment as usual; and 3) assess user experience and barriers to the implementation of AcamproSync, guided by the Reach-Effectiveness-Adoption, Implementation, and Maintenance (RE-AIM) framework. By addressing key gaps in adherence to MAUD, this project has the potential to significantly impact AUD treatment outcomes. This study will also provide foundational data for the development of a scalable digital health-based intervention to improve adherence that has trans-NIH applicability to other high priority health issues.