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Not yet recruiting NCT07553377

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

No phase Interventional Alcohol Use Disorder Alcohol Associated Liver Disease Medications for Alcohol Use Disorder Behavioral Medicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AcamproSync.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Alcohol Associated Liver Disease, Medications for Alcohol Use Disorder, Behavioral Medicine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Ability to enroll participants- Feasibility [Time frame: Baseline and 30 days]
  • Retention- Feasibility [Time frame: Baseline and 30 days]
  • Feasibility of Intervention Measure (FIM)- Feasibility [Time frame: Baseline and 30 days]
  • Acceptability of Intervention (AIM)- Acceptability [Time frame: Baseline and 30 days]
  • Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability [Time frame: Baseline and 30 days]
  • Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability [Time frame: Baseline and 30 days]
  • Mean System Usability Scale (SUS) score- Usability [Time frame: Baseline and 30 days]
Secondary outcome measures (7)
  • DPS Accuracy [Time frame: Baseline and 30 days]
  • Heavy drinking frequency [Time frame: Baseline and 30 days]
  • Abstinence frequency [Time frame: Baseline and 30 days]
  • Linkage to AUD treatment [Time frame: Baseline and 30 days]
  • Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R) [Time frame: Baseline and 30 days]
  • Acamprosate adherence by self report [Time frame: Day 30]
  • DPS Acamprosate adherence [Time frame: Day 30]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Yale — New Haven

Identifiers

NCT: NCT07553377 · Goldfine 033126 · 1K23AA032563-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗