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

Zealand University Hospital

Status: Enrolling

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

Treatments: Behavioral: Offer of specialized alcohol use disorder treatment in the hepatology clinic

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06493773

SJ-895

Details and patient eligibility

About

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.

Full description

The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in the hepatology clinic to newly diagnosed ALD patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of participants in the study. From november, 2025, the investigators will start to randomize eligible participants.

Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation.

Patients in the intervention group will receive standard care in addition to an offer of AUD treatment in the hepatology clinic.

Enrollment: 221 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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221 participants in 2 patient groups

Standard care group

No Intervention group

Description:

Patients randomized to standard care will receive standard supporting care by their care providers, entailing education on the nature of alcohol-related liver disease and encouragement to abstain from alcohol use.

Intervention group

Experimental group

Description:

Patients randomized to the intervention group.

Treatment:

Behavioral: Offer of specialized alcohol use disorder treatment in the hepatology clinic