Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption (BAWIC)

February 20, 2025 updated by: Jordi Sanchez-Delgado, Corporacion Parc Tauli

Safety and Efficacy Assessment of Baclofen for Alcohol Withdrawal in Patients With Chronic Liver Disease and Active Alcohol Consumption

This study examines the safety and effectiveness of baclofen as a treatment for alcohol withdrawal in patients with chronic liver disease who continue drinking. It aims to evaluate baclofen's ability to promote alcohol abstinence or reduction while monitoring adverse effects. Secondary outcomes include liver function changes, hospital readmissions, and complications of cirrhosis.

Alcohol consumption worsens liver disease prognosis, yet alcohol use disorder (AUD) often goes untreated. Baclofen, which is safe for patients with liver impairment, is recommended as a first-line treatment for AUD in chronic liver disease. This prospective study collects data from patients treated with baclofen at Parc Taulí Hospital, analyzing outcomes at three and six months to assess abstinence, alcohol reduction, and adverse effects.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The medical management of alcohol use disorder (AUD) requires a multidisciplinary approach, involving psychiatrists, psychologists, and hepatologists. Treatment often combines pharmacotherapy with psychosocial interventions to achieve and maintain abstinence. Over the years, various anti-craving medications have been used. Due to its renal metabolism, rather than hepatic, baclofen is considered safe for individuals with chronic liver disease and is currently the first-line pharmacological agent for patients with AUD and secondary liver disease.

Despite clinical guidelines recommending baclofen as the preferred medication to reduce alcohol consumption in patients with chronic liver disease, its use remains limited. Moreover, no published data or communications exist regarding its application in the investigators specific context.

The primary objectives of this study are to assess the rate of abstinence maintenance, evaluate the reported reduction in alcohol consumption, and assess the safety of baclofen as a treatment for alcohol abstinence.

The secondary objectives include evaluating changes in liver function related to alcohol abstinence or consumption reduction. Liver function will be assessed using the CHILD Score (Child-Turcotte-Pugh, CTP) and the MELD Score (Model for End-Stage Liver Disease), both of which are essential tools for predicting prognosis in patients with cirrhosis.

Treatment initiation may occur across various hospital settings, including inpatient units during hospitalizations, outpatient hepatology services, and psychiatric services.

The investigators will evaluate the efficacy and safety of baclofen through regular follow-ups with patients who initiate treatment. Data collection methods will include patient interviews, self-reported abstinence, blood tests to assess liver function, and baseline information on active drinking behavior. Follow-up will be conducted over a period of six months

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A single-center retrospective study of patients with alcohol-related chronic liver disease (alcoholic liver disease and cirrhosis) who receive baclofen as treatment for alcohol dependence.

The treatments have been initiated from different hospital settings: 1) Inpatient units during hospitalization for complications of liver disease, 2) Outpatient care setting provided by hepatologists 3) Patiens with cirrhosis in emergency care setting and 4) Outpatient care setting provided by psychiatrists.

Description

Inclusion Criteria:

  • Patients with chronic liver disease at any stage
  • Active alcohol consumption
  • Use of baclofen for the treatment of alcohol dependence.

Exclusion Criteria:

  • Severe psychiatric illness requiring other psychotropic pharmacological treatments
  • Organic or functional renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with alcohol-related cirrhosis who persist in active alcohol consumption.
Patients with alcohol-related cirrhosis with active alcohol consumption and are being monitored in outpatient hepatology clinics. Baclofen treatment will be prescribed by hepatologists and/or psychiatrists and all patients will be referred for follow-up in outpatient addiction clinics.
Drug: Baclofen
Safety and effectiveness of baclofen as a treatment for alcohol withdrawal in patients with chronic liver disease. The investigators will administer baclofen in increasing doses up to a maximum dose of 10 mg every 8 hours, evaluating the drug's tolerance and its effectiveness in achieving alcohol abstinence. Baclofen will be administered during the patient's hospitalization for decompensation of their liver disease, in patients followed up as outpatients in hepatology clinics, and in those managed as outpatients by psychiatrists specializing in addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients who achieve abstinence
Time Frame: During 6 months
The investigators will report, through clinical interviews, the percentage of patients who have stopped drinking
During 6 months
Rate of patients who reduce alcohol consumption
Time Frame: During 6 months
The investigators will report, through clinical interviews, the percentage of patients who have reduced alcohol consumption
During 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients discontinuing treatment due to side effects
Time Frame: During 6 months
The investigators will report, through clinical interviews, the tolerance and side effects of the baclofen
During 6 months
CHILD and MELD score improvement if abstinence is achieve
Time Frame: During 6 months

The investigators will evaluate the improvement in liver function in relation to abstinence measured by CHILD and MELD scores.

The Child-Pugh classification assesses the prognosis of cirrhosis, using five parameters: Total Bilirubin (mg/dL), Serum Albumin (g/dL), Prothrombin Time (PT) or INR, Ascites, and Hepatic Encephalopathy. Each is scored from 1 to 3 points, with higher scores indicating worse liver function. The total score categorizes patients into: Class A (5-6 points) - mild disease with good liver function, Class B (7-9 points) - moderate severity, and Class C (10-15 points) - severe liver dysfunction with poor prognosis.

The MELD score (Model for End-Stage Liver Disease) predicts short-term mortality using Serum Bilirubin, Serum Creatinine, and INR. Low MELD (<15) suggests low mortality risk, High MELD (≥15) indicates significant dysfunction, and Very High MELD (≥30) reflects critical liver failure, prioritizing for transplantation.
During 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Jordi Sánchez Delgado, MD. PhD, Consorci Corporació Sanitària Parc Taulí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/5106 (Other Identifier: Consorci Corporació Sanitària Parc Taulí)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share our preliminary results with other interested researchers in case they are interested in conducting a multicenter study

IPD Sharing Time Frame

The supporting information will be available in january'26 till january'27

IPD Sharing Access Criteria

Other investigators will be able to access to this information by contacting by email with the principal investigator

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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