NCT06493773

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-15
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-07-10
• Last updated: 2025-11-18

Locations

1 site across 1 country: Denmark