Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Offer of specialized alcohol use disorder treatment in the hepatology clinic.
- Who it may be relevant to
- Registry conditions: Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Self-reported alcohol abstinence in the last 30 days at 3 months followup [Time frame: 3 months after baseline]
- Rate of AUD treatment [Time frame: 6 and 12 months after baseline]
- Rate of individuel AUD treatment [Time frame: 6 and 12 months after baseline]
- Rate of AUD treatment [Time frame: 6 and 12 months from baseline]
- Reduction in drinks per week [Time frame: 3, 6 and 12 months from baseline]
- Reduction in phosphatidylethanol [Time frame: 6 and 12 months from baseline]
- Complications from liver disease [Time frame: 3 years from baseline]
- All-cause mortality [Time frame: 3 years from baseline]
- Progression of liver disease [Time frame: 3 years from baseline]
- Duration of AUD treatment [Time frame: 6 and 12 months from baseline]
- Group AUD treatment sessions [Time frame: 6 and 12 months from baseline]
- Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months [Time frame: 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Medicine, Zealand University Hospital — Køge
Identifiers
NCT: NCT06493773 · SJ-895