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

NCT07553377 | Not Yet Recruiting

• 2 other identifiers: Goldfine 0331261K23AA032563-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Medications for Alcohol Use Disorder; Behavioral Medicine; Alcohol Associated Liver Disease; Medication Adherence

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• DPS Accuracy

  Baseline and 30 days

• Heavy drinking frequency

  Baseline and 30 days

• Abstinence frequency

  Baseline and 30 days

• Linkage to AUD treatment

  Baseline and 30 days

• Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)

  Baseline and 30 days

Study Arms (2)

AcamproSync

EXPERIMENTAL

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

Control (Treatment as Usual)

NO INTERVENTION

Participants will receive treatment as usual.

Interventions

AcamproSync DEVICE

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.

AcamproSync

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being treated for AUD
• Diagnosed with DSM-5 moderate to severe AUD
• Screens positive ALD utilizing non-invasive blood tests
• Planned initiation of acamprosate

You may not qualify if:

• History of hypersensitivity to acamprosate
• Allergy to magnesium or silver
• Severe renal impairment (creatinine clearance of 30mL/min or less)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Alcoholism; Medication Adherence

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Charlotte Goldfine

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Goldfine, MD

CONTACT

203-785-2353; charlotte.goldfine@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with alcohol use disorder and alcohol-associated liver disease

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)