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NCT Number: NCT06493773

Alcohol Misuse Treatment 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.

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Key information

Conditions

Liver Diseases, Alcoholic Alcohol Use Disorder Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Digestive System Diseases Health Behavior Liver Disease; Alcohol-Related Liver Diseases Mental Disorders Substance-Related Disorders Treatment Adherence Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Zealand University Hospital

Køge, 4600, Denmark

Location status: Recruiting

Location contact

Gro Askgaard

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months

    Time frame: 6 months after baseline

    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

Secondary outcomes

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

    Time frame: 3 months after baseline

    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.

  2. Rate of AUD treatment

    Time frame: 6 and 12 months after baseline

    Any treatment for alcohol use disorder after 6 and 12 months

  3. Rate of individuel AUD treatment

    Time frame: 6 and 12 months after baseline

    Any individuel treatment for alcohol use disorder after 6 and 12 months

  4. Rate of AUD treatment

    Time frame: 6 and 12 months from baseline

    Number of received sessions of treatment for alcohol use disorder after 6 and 12 months

  5. Reduction in drinks per week

    Time frame: 3, 6 and 12 months from baseline

    Reduction in drinks per week after 3, 6 and 12 months compared to baseline (yes or no)

  6. Reduction in phosphatidylethanol

    Time frame: 6 and 12 months from baseline

    Reduction in phosphatidylethanol value at 6 and 12 months compared to baseline (yes or no)

  7. Complications from liver disease

    Time frame: 3 years from baseline

    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

  8. All-cause mortality

    Time frame: 3 years from baseline

    time to death

  9. Progression of liver disease

    Time frame: 3 years from baseline

    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

  10. Duration of AUD treatment

    Time frame: 6 and 12 months from baseline

    Duration of AUD treatment

  11. Group AUD treatment sessions

    Time frame: 6 and 12 months from baseline

    Amount of group AUD treatment sessions

  12. Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emil B B Fromberg, Cand.scient.san

CONTACT

[email protected]

51184036 ext. +45

Gro Askgaard, PhD

CONTACT

[email protected]

60142280 ext. +45

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Center for Clinical Research and Prevention
  • Novavi Outpatient Clinics

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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