NCT05855031

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2023May 2027

First Submitted

Initial submission to the registry

April 20, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

April 20, 2023

Last Update Submit

May 15, 2023

Conditions

Alcoholic Liver DiseaseAlcohol Use DisorderAlcohol AbuseAlcoholismFibrosis, LiverAlcohol-Related Disorders

Keywords

ScreeningFibroscanLiver stiffness measurementabstinence

Outcome Measures

Primary Outcomes (1)

  • Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization

    Assessed By telephone interview or health record

    Assessed 6 months after randomization

Secondary Outcomes (2)

  • Heavy drinking days last 30 days

    Assessed 6 months after since randomization

  • Change in AUDIT-C score (yes or no) since randomization

    6 months after randomization

Other Outcomes (5)

  • Improvement or no decrease in motivation to cut down on alcohol (yes or no)

    6 months after randomization

  • Improvement or no decrease in physical and mental health-related quality of life (SF-12) (yes or no), calculated as the difference between baseline and follow-up.

    Assessed 6 months after randomization

  • Comparing abstinence or light consumption last 30 days between those in the intervention group with a screen negative result with those in the control group.

    Assessed 6 months after randomization

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.

Diagnostic Test: Transient Elastography

Control

NO INTERVENTION

An invitation to screening by blood sampling with Fib-4

Interventions

Transient ElastographyDIAGNOSTIC_TEST

One transient elastography 1-2 weeks after randomization

Also known as: Fibroscan, Liver stiffness measurement
Intervention

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not speaking Danish or English
  • Severe liver disease (known by the participant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novavi Køge

Køge, 4600, Denmark

RECRUITING

Novavi Roskilde

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

  • Dahlin P, Jepsen P, Molzen L, Madsen LG, Wegmann During S, Benthien KS, Winther-Jensen M, Grew JC, Kirk JW, Jensen KJ, Petersen J, Askgaard G. The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder-study protocol for a randomized controlled study. Trials. 2025 Oct 28;26(1):448. doi: 10.1186/s13063-025-09151-8.

    PMID: 41152905DERIVED

MeSH Terms

Conditions

Liver Diseases, AlcoholicAlcoholismLiver CirrhosisAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gro Askgaard, PHD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille Dahlin, MD

CONTACT

+45 30291114pedah@regionsjaelland.dk

Gro Askgaard, PHD

CONTACT

gras@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized concealed allocation to intervention or control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 11, 2023

Study Start

May 8, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)