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Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

NCT06493773 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-11-18

No results posted yet for this study

Summary

To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.

Conditions

  • Liver Diseases, Alcoholic
  • Alcohol Use Disorder
  • Treatment Adherence
  • Alcoholism
  • Liver Disease; Alcohol-Related

Interventions

BEHAVIORAL

Offer of specialized alcohol use disorder treatment in the hepatology clinic

Patients are offered specialized alcohol use disorder treatment in the hepatology clinic by an experienced AUD therapist from the AUD facility. Also medical AUD treatments will be offered to support abstinence.

Sponsors & Collaborators

  • Center for Clinical Research and Prevention

    collaborator NETWORK

  • Novavi Outpatient Clinics

    collaborator UNKNOWN

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Lone G Madsen, PhD · Zealand University Hospital, Koege

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2029-04-01
Completion
2029-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493773 on ClinicalTrials.gov