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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07553377
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 31, 2027
Status verified
Apr 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • No Intervention: Control (Treatment as Usual)
    Participants will receive treatment as usual.

Primary Outcome Measure

Ability to enroll participants- Feasibility [ Time Frame: Baseline and 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
YaleNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Yale· New Haven, CT

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