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NCT Number: NCT07553377

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol Associated Liver Disease Alcohol-Related Disorders Alcoholism Behavior Behavioral Medicine Chemically-Induced Disorders Health Behavior Medication Adherence Medications for Alcohol Use Disorder Mental Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Ability to enroll participants- Feasibility

    Time frame: Baseline and 30 days

    Number of participants enrolled out of all screened.

  2. Retention- Feasibility

    Time frame: Baseline and 30 days

    Number of participants enrolled that complete the 30 day follow-up.

  3. Feasibility of Intervention Measure (FIM)- Feasibility

    Time frame: Baseline and 30 days

    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.

  4. Acceptability of Intervention (AIM)- Acceptability

    Time frame: Baseline and 30 days

    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.

  5. Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability

    Time frame: Baseline and 30 days

    PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability.

  6. Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability

    Time frame: Baseline and 30 days

    Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability

  7. Mean System Usability Scale (SUS) score- Usability

    Time frame: Baseline and 30 days

    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.

Secondary outcomes

  1. DPS Accuracy

    Time frame: Baseline and 30 days

    Correlation coefficient between DPS recorded adherence and pill counts.

  2. Heavy drinking frequency

    Time frame: Baseline and 30 days

    Mean days heavy drinking in the last thirty days

  3. Abstinence frequency

    Time frame: Baseline and 30 days

    Mean days drinking abstinence in the last thirty days

  4. Linkage to AUD treatment

    Time frame: Baseline and 30 days

    Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment

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

    Time frame: Baseline and 30 days

    Mean score from 1 to 7 with higher scores indicating more severe alcohol craving.

  6. Acamprosate adherence by self report

    Time frame: Day 30

    Self report pill counts at the 30 day visit

  7. DPS Acamprosate adherence

    Time frame: Day 30

    DPS report pill counts at the 30 day visit

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Goldfine, MD

CONTACT

[email protected]

203-785-2353

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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