The Liver Care Trial

Alcohol Use Disorder Clinical Trial

Official title:

The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855031
• Other study ID #: SJ-995
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2023
• Source: Zealand University Hospital
• Contact: Pernille Dahlin, MD
• Phone: +45 30291114
• Email: pedah[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: May 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol-Related Disorders
• Alcoholic Liver Disease
• Alcoholism
• Disease
• Fibrosis, Liver
• Liver Cirrhosis
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Diagnostic Test:
• Transient Elastography
One transient elastography 1-2 weeks after randomization

Locations

Country	Name	City	State
Denmark	Novavi Køge	Køge
Denmark	Novavi Roskilde	Roskilde

Sponsors (5)

Lead Sponsor	Collaborator
Zealand University Hospital	Aarhus University Hospital, Frederiksberg University Hospital, Novavi, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement or no decrease in motivation to cut down on alcohol (yes or no)	Assessed by telephone interview via questionnaire	6 months after randomization
Other	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.	SF 12 (12-Item Short Form Survey) is a validated self-reported outcome measure assessing the impact of health on an individual's everyday life	Assessed 6 months after randomization
Other	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.	Light consumption < 10 units/week	Assessed 6 months after randomization
Other	Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan		Assessed 6 months after randomization
Other	Improvement or no decrease in smoking (yes/no)	By logistic regression	Assessed 6 months after randomization
Primary	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	Heavy drinking days last 30 days	Assessed by telephone interview or health record	Assessed 6 months after since randomization
Secondary	Change in AUDIT-C score (yes or no) since randomization	AUDIT: the Alcohol Use Disorders Identification Test is a validated manual for use in primary care to identify persons with hazardous and harmful patterns of alcohol consumption	6 months after randomization