Evaluating liver disease screening for individuals with alcohol use disorder
The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study
This study tests if screening for liver disease with a special measurement helps people in alcohol treatment stay sober or drink less over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 2 sites (Køge and 1 other locations) |
| Trial ID | NCT05855031 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of screening for liver disease using liver stiffness measurement in individuals undergoing treatment for alcohol use disorder. Participants will be randomly assigned to either receive an invitation for liver stiffness measurement and blood sampling or just blood sampling as a control. The primary outcome will be measured by the level of abstinence or light alcohol consumption after six months. The study focuses on individuals without a prior history of liver disease.
Who should consider this trial
Good fit: Ideal candidates are individuals attending outpatient treatment for alcohol use disorder who can provide informed consent.
Not a fit: Patients with severe liver disease or those who do not speak Danish or English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of alcohol use disorder and better liver health outcomes for patients.
How similar studies have performed: Other studies have shown promise in using liver stiffness measurement for liver disease screening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde * Informed written consent Exclusion Criteria: * Not speaking Danish or English * Severe liver disease (known by the participant)
Where this trial is running
Køge and 1 other locations
- Novavi Køge — Køge, Denmark (Recruiting)
- Novavi Roskilde — Roskilde, Denmark (Recruiting)
Study contacts
- Principal investigator: Gro Askgaard, PHD — Zealand University Hospital
- Study coordinator: Pernille Dahlin, MD
- Email: pedah@regionsjaelland.dk
- Phone: +45 30291114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.