Referral to alcohol treatment for patients with liver disease
Official title: Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Run by Zealand University Hospital · NCT06493773 · Data updated 2026-11-12
This study tests whether sending newly diagnosed patients with alcohol-related liver disease to specialized treatment can help them stop drinking better than just regular care alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 221 (estimated) |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge, Køge) |
| Status | Recruiting |
| Started | November 15, 2025 |
| Main results expected | April 1, 2029 |
| Study ends | April 1, 2029 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06493773 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old, newly diagnosed with alcohol-related liver disease, and consuming excessive alcohol.
✕Probably not a fit
Patients who are currently undergoing AUD treatment or those who do not speak Danish may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of systematically referring newly diagnosed patients with alcohol-related liver disease (ALD) to specialized alcohol use disorder (AUD) treatment. It is a randomized controlled trial comparing the outcomes of patients receiving standard care versus those receiving standard care plus a referral to AUD treatment. The primary goal is to assess the rate of alcohol abstinence after six months. Participants will be randomized during their first visit, and the study will utilize an existing observational cohort for control comparisons.
Why it matters
Potential benefit: If successful, this approach could significantly increase the rates of alcohol abstinence in patients with alcohol-related liver disease.
How similar studies have gone: Other studies have shown promising results in improving treatment adherence and outcomes for patients with alcohol use disorders, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Medicine, Zealand University Hospital
Køge, Køge, Denmark Recruiting
Study contacts
- Study coordinator: Emil B B Fromberg, Cand.scient.san
- Email: ebuf@regionsjaelland.dk
- Phone: 51184036
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.