Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-09; most recent amendment 2025-11-14.
Status change: Not Yet Recruiting → Recruiting 2024-07-29
Trial Details
NCT Number NCT06493773
Lead Sponsor Zealand University Hospital
Collaborators: Center for Clinical Research and Prevention, Novavi Outpatient Clinics
Conditions Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism, Liver Disease; Alcohol-Related
Enrollment 221 participants
Start Date 2025-11-15
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-18