Digital Pill System for Alcohol-Related Liver Disease

CG
Overseen ByCharlotte Goldfine, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Acamprosate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

CG

Charlotte Goldfine

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

* Being treated for AUD
* Diagnosed with DSM-5 moderate to severe AUD
* Screens positive ALD utilizing non-invasive blood tests
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the AcamproSync system, receive personalized adherence intervention, and engage in self-management through ecological momentary assessments

4 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AcamproSync

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: AcamproSyncExperimental Treatment1 Intervention
Group II: Control (Treatment as Usual)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+