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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholism; Treatment Adherence; Alcohol Use Disorder; Liver Diseases, Alcoholic; Liver Disease; Alcohol-Related
• Intervention / Treatment: Behavioral: Offer of specialized alcohol use disorder treatment in the hepatology clinic

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.

• Study Type: Interventional
• Enrollment (Estimated): 221
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gro Askgaard, PhD; Phone Number: +45 60142280; Email: gras@regionsjaelland.dk
• Study Contact Backup: Name: Emil B B Fromberg, Cand.scient.san; Phone Number: +45 51184036; Email: ebuf@regionsjaelland.dk

Study Locations

• Denmark
  • Køge
    • Køge, Køge, Denmark, 4600
      • Recruiting
      • Department of Medicine, Zealand University Hospital
      • Contact: Gro Askgaard; Email: gask@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care group; 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.
Experimental: Intervention group; Patients randomized to the intervention group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months	Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 6 months assessed by the timeline followback method (questionnaire) and review of medical charts and measurement of phosphatidylethanol at 6 months	6 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications from liver disease	Time to first decompensation event, which is defined as variceal haemorrhage, ascites grade 2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse	3 years from baseline
All-cause mortality	time to death	3 years from baseline
Progression of liver disease	Progression in liver fibrosis grade assessed by transient elastography or progression to a worse Child-Pugh class (A to B or C and B to C	3 years from baseline
Self-reported alcohol abstinence in the last 30 days at 3 months followup	Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 3 months and no indications of alcohol use in medical charts.	3 months after baseline
Rate of AUD treatment	Any treatment for alcohol use disorder after 6 and 12 months	6 and 12 months after baseline
Rate of individuel AUD treatment	Any individuel treatment for alcohol use disorder after 6 and 12 months	6 and 12 months after baseline
Rate of AUD treatment	Number of received sessions of treatment for alcohol use disorder after 6 and 12 months	6 and 12 months from baseline
Reduction in drinks per week	Reduction in drinks per week after 3, 6 and 12 months compared to baseline (yes or no)	3, 6 and 12 months from baseline
Reduction in phosphatidylethanol	Reduction in phosphatidylethanol value at 6 and 12 months compared to baseline (yes or no)	6 and 12 months from baseline
Duration of AUD treatment	Duration of AUD treatment	6 and 12 months from baseline
Group AUD treatment sessions	Amount of group AUD treatment sessions	6 and 12 months from baseline
Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months	Self-reported alcohol abstinence last 30 days by 12 months assessed by the timeline followback method (questionnaire) and review of electronic medical records in combination with measured phosphatidylethanol level.	12 months

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Center for Clinical Research and Prevention; Novavi Outpatient Clinics
• Investigators: Study Chair: Lone G Madsen, PhD, Zealand University Hospital, Koege

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: randomized clinical trial; Alcohol use disorder; Alcohol treatment; Alcoholic liver disease; hepatology clinic
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Behavior; Health Behavior; Alcoholism; Liver Diseases; Liver Diseases, Alcoholic; Treatment Adherence and Compliance; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: SJ-895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because of the relatively low number of patients, data are considered highly sensitive and cannot allow sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No