A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease
Yale University
Summary
This study seeks to develop and test a novel digital pill system (DPS) that measures real-time medication ingestion and pairs it with a cognitive behavioral therapy (CBT)-based intervention to provide personalized, data-driven adherence support, with the long-term goal of providing new and improved personalized support and increase medication adherence for people with AUD and ALD.
Description
The primary objective is to develop and examine the feasibility and acceptability of AcamproSync, an adherence intervention that combines a digital pill system (DPS) technology with personalized adherence feedback and support. This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot randomized control trial of AcamproSync compared to treatment as usual will be conducted to assess the feasibility and acceptability of the adherence intervention paired with DPS (AcamproSync). Secondarily, change in adherence, numb…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Being treated for AUD * Diagnosed with DSM-5 moderate to severe AUD * Screens positive ALD utilizing non-invasive blood tests * Planned initiation of acamprosate Exclusion Criteria: * History of hypersensitivity to acamprosate * Allergy to magnesium or silver * Severe renal impairment (creatinine clearance of 30mL/min or less)
Interventions
- DeviceAcamproSync
AcamproSync, is an innovative behavioral intervention to support acamprosate adherence in individuals with ALD. It comprises three components: 1) a digital pill system that directly measures acamprosate adherence, 2) a personalized, adherence intervention grounded in the empiric LifeSteps Cognitive Behavioral Therapy framework and 3) self-management and introspection into alcohol use patterns through ecological momentary assessments (EMA) of drinking and alcohol craving.
Location
- YaleNew Haven, Connecticut