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

NCT06493773 | Recruiting

• 1 other identifier: SJ-895
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Alcoholic liver disease; Alcohol use disorder; Alcohol treatment; randomized clinical trial; hepatology clinic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Self-reported alcohol abstinence in the last 30 days at 3 months followup

  3 months after baseline

• Rate of AUD treatment

  6 and 12 months after baseline

• Rate of individuel AUD treatment

  6 and 12 months after baseline

• Rate of AUD treatment

  6 and 12 months from baseline

• Reduction in drinks per week

  3, 6 and 12 months from baseline

Study Arms (2)

Standard care group

NO INTERVENTION

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

Patients randomized to the intervention group.

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

Interventions

Offer of specialized alcohol use disorder treatment in the hepatology clinic BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Center for Clinical Research and Prevention: collaborator
• Novavi Outpatient Clinics: collaborator

Study Sites (1)

Department of Medicine, Zealand University Hospital

Køge, Køge, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Alcoholism; Treatment Adherence and Compliance; Liver Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Lone G Madsen, PhD

  Zealand University Hospital, Koege

  STUDY CHAIR

Central Study Contacts

Emil B B Fromberg, Cand.scient.san

CONTACT

51184036; ebuf@regionsjaelland.dk

Gro Askgaard, PhD

CONTACT

60142280; gras@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There is follow-up for each individual participant conducted by personnel blinded to the randomization and consisting of: 1) telephone contact with interview about alcohol consumption using the time-line follow-back method conducted at three time points after 1, 3 and 6 months, 2) measurement of phosphatidyl ethanol after 6 months, and 3) electronic health records from hospital and alcohol treatment facility after 6 months. Use of hypothesis blinding for patients about the study aim. Usual care providers in the hospital such as physicians and nurses will not see any description of AUD treatment in the medical charts. Analyses will be performed in a blinded data set with treatment allocation labeled "A" and "B". Prior to this, the statistical analysis plan will be completed, signed, and uploaded at clinicaltrials.gov, and the data set will be locked. Unblinding will not occur until all analyses are performed (expected autumn 2028).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 10, 2024
• Study Start: November 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)