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

• Conditions: Alcoholic Cirrhosis; Alcohol Abstinence; Alcohol Withdrawal; Medication Toxicity; Medication Adherence
• Interventions: Drug: Baclofen

• Registration Number: NCT06840652
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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.

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 Timeline

• Study Start: 2022-12-22
• Study First Submitted: 2025-01-11
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with alcohol-related cirrhosis who persist in active alcohol consumption.	Baclofen	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.

Primary Outcome Measures

Name	Time	Method
Rate of patients who achieve abstinence	During 6 months	The investigators will report, through clinical interviews, the percentage of patients who have stopped drinking
Rate of patients who reduce alcohol consumption	During 6 months	The investigators will report, through clinical interviews, the percentage of patients who have reduced alcohol consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Consorci Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain