A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Adherence; Alcohol Use Disorder; Behavioral Medicine; Alcohol Associated Liver Disease; Medications for Alcohol Use Disorder
• Intervention / Treatment: Device: AcamproSync

Detailed 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, number of days drinking, and number of days abstinent will be explored. The study will take place at Yale New Haven Hospital, among people with alcohol use disorder and alcohol-associated liver disease.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Goldfine, MD; Phone Number: 203-785-2353; Email: charlotte.goldfine@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AcamproSync; Participants will 1.) use the AcamproSync system which directly measures acamprosate adherence, 2) receive 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.	Device: AcamproSync; 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.
No Intervention: Control (Treatment as Usual); Participants will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to enroll participants- Feasibility	Number of participants enrolled out of all screened.	Baseline and 30 days
Retention- Feasibility	Number of participants enrolled that complete the 30 day follow-up.	Baseline and 30 days
Feasibility of Intervention Measure (FIM)- Feasibility	Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility.	Baseline and 30 days
Acceptability of Intervention (AIM)- Acceptability	Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Total score 1-5 with higher scores indicating greater acceptability.	Baseline and 30 days
Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability	PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability.	Baseline and 30 days
Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability	Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability	Baseline and 30 days
Mean System Usability Scale (SUS) score- Usability	SUS is a reliable, 10-item questionnaire used to measure the subjective usability of products, websites, or software, producing a score from 0 to 100. Higher scores indicate more usability.	Baseline and 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DPS Accuracy	Correlation coefficient between DPS recorded adherence and pill counts.	Baseline and 30 days
Heavy drinking frequency	Mean days heavy drinking in the last thirty days	Baseline and 30 days
Abstinence frequency	Mean days drinking abstinence in the last thirty days	Baseline and 30 days
Linkage to AUD treatment	Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment	Baseline and 30 days
Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)	Mean score from 1 to 7 with higher scores indicating more severe alcohol craving.	Baseline and 30 days
Acamprosate adherence by self report	Self report pill counts at the 30 day visit	Day 30
DPS Acamprosate adherence	DPS report pill counts at the 30 day visit	Day 30

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Charlotte Goldfine, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Alcoholism; Medication Adherence
• Other Study ID Numbers: Goldfine 033126; 1K23AA032563-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data will be de-identified by removing protected identifiers. This will be clearly explained to participants as part of the human subjects consent process. The data generated through this project will be deposited into Yale Dataverse data repository and the NIAAA Data Archive (NIAAADA). Yale Dataverse is an open-access, online data repository available to investigators at Yale University. The NIAAADA a data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA) for de-identified individual-level data that can be made available to the general research community.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No