NCT06493773 Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
| NCT ID | NCT06493773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Liver Diseases, Alcoholic |
| Study Type | INTERVENTIONAL |
| Enrollment | 221 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 221 participants in total. It began in 2025-11-15 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Lone G Madsen, PhD
STUDY CHAIR
Zealand University Hospital, Koege
Frequently Asked Questions
Who can join the NCT06493773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Diseases, Alcoholic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06493773 currently recruiting?
Yes, NCT06493773 is actively recruiting participants. Contact the research team at ebuf@regionsjaelland.dk for enrollment information.
Where is the NCT06493773 trial being conducted?
This trial is being conducted at Køge, Denmark.
Who is sponsoring the NCT06493773 clinical trial?
NCT06493773 is sponsored by Zealand University Hospital. The principal investigator is Lone G Madsen, PhD at Zealand University Hospital, Koege. The trial plans to enroll 221 participants.