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ENROLLING BY INVITATION
NCT06840652

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

Sponsor: Corporacion Parc Tauli

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2022-12-22

Completion Date

2026-07

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

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

Locations (1)

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain