RecruitingNot ApplicableNCT06493773

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

Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

Sponsor

Zealand University Hospital

Enrollment

221 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age \> 18 years
Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.
A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.
Excessive alcohol consumption defined as \>7 units/week for women and \>14 units/week for men within the previous year.
The patient is able to understand the purpose of the study and give informed oral and written consent to participate.

Exclusion Criteria3

Not enough proficiency in Danish to participate in interviews and questionnaires.
Pregnancy
Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.

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Interventions

BEHAVIORALOffer 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.