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Smart pills could boost medication adherence for Alcohol-Related liver disease

NCT ID NCT07553377

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a digital pill system that tracks when people with alcohol-related liver disease take their medication (acamprosate) and provides personalized support to help them stay on track. The system includes a sensor in the pill, a wearable patch, and a smartphone app with coaching based on cognitive behavioral therapy. The goal is to see if this approach is feasible and acceptable for improving medication adherence and reducing heavy drinking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acamprosate
What this could lead to
If successful, this could provide a new way to help people with alcohol-related liver disease stick to their medication, potentially improving treatment outcomes.
What could go wrong
This is a small, early feasibility study with only 50 participants, so results may not apply to everyone. The digital pill system may not be acceptable or easy to use for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2027

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcoholic liver disease Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder Alcohol-associated liver disease Behavioral medicine Medication adherence Medications for alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale

    New Haven, Connecticut, 06520, United States

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