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

NCT06840652 | Enrolling By Invitation DMC

• 1 other identifier: 2023/5106
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Cirrhosis; Alcohol Abstinence; Alcohol Withdrawal; Medication Toxicity; Medication Adherence

Keywords

alcohol withdrawal; baclofen; alcoholic cirrhosis; alcohol abstinence

Outcome Measures

Primary Outcomes (2)

• Rate of patients who achieve abstinence

  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

  The investigators will report, through clinical interviews, the percentage of patients who have reduced alcohol consumption

  During 6 months

Secondary Outcomes (2)

• Rate of patients discontinuing treatment due to side effects

  During 6 months

• CHILD and MELD score improvement if abstinence is achieve

  During 6 months

Study Arms (1)

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

Interventions

Baclofen DRUG

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

Patients with alcohol-related cirrhosis who persist in active alcohol consumption.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (6)

• Agabio R, Sinclair JM, Addolorato G, Aubin HJ, Beraha EM, Caputo F, Chick JD, de La Selle P, Franchitto N, Garbutt JC, Haber PS, Heydtmann M, Jaury P, Lingford-Hughes AR, Morley KC, Muller CA, Owens L, Pastor A, Paterson LM, Pelissier F, Rolland B, Stafford A, Thompson A, van den Brink W, de Beaurepaire R, Leggio L. Baclofen for the treatment of alcohol use disorder: the Cagliari Statement. Lancet Psychiatry. 2018 Dec;5(12):957-960. doi: 10.1016/S2215-0366(18)30303-1. Epub 2018 Nov 6. No abstract available.

  PMID: 30413394 BACKGROUND

• Duan F, Zhai H, Liu C, Chang C, Song S, Li J, Cheng J, Yang S. Systematic review and meta-analysis: Efficacy and safety of baclofen in patients with alcohol use disorder co-morbid liver diseases. J Psychiatr Res. 2023 Aug;164:477-484. doi: 10.1016/j.jpsychires.2023.06.042. Epub 2023 Jun 30.

  PMID: 37441998 BACKGROUND

• Mekonen T, Chan GCK, Connor J, Hall W, Hides L, Leung J. Treatment rates for alcohol use disorders: a systematic review and meta-analysis. Addiction. 2021 Oct;116(10):2617-2634. doi: 10.1111/add.15357. Epub 2021 Jan 12.

  PMID: 33245581 BACKGROUND

• Glantz MD, Bharat C, Degenhardt L, Sampson NA, Scott KM, Lim CCW, Al-Hamzawi A, Alonso J, Andrade LH, Cardoso G, De Girolamo G, Gureje O, He Y, Hinkov H, Karam EG, Karam G, Kovess-Masfety V, Lasebikan V, Lee S, Levinson D, McGrath J, Medina-Mora ME, Mihaescu-Pintia C, Mneimneh Z, Moskalewicz J, Navarro-Mateu F, Posada-Villa J, Rapsey C, Stagnaro JC, Tachimori H, Ten Have M, Tintle N, Torres Y, Williams DR, Ziv Y, Kessler RC; WHO World Mental Health Survey Collaborators. The epidemiology of alcohol use disorders cross-nationally: Findings from the World Mental Health Surveys. Addict Behav. 2020 Mar;102:106128. doi: 10.1016/j.addbeh.2019.106128. Epub 2019 Sep 16.

  PMID: 31865172 BACKGROUND

• Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009 Jun 27;373(9682):2223-33. doi: 10.1016/S0140-6736(09)60746-7.

  PMID: 19560604 RESULT

• GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23.

  PMID: 30146330 RESULT

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Alcohol Abstinence; Drug-Related Side Effects and Adverse Reactions; Medication Adherence

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jordi Sánchez Delgado, MD. PhD

  Consorci Corporació Sanitària Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Hepatology Hospitalization Unit

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: February 21, 2025
• Study Start: December 22, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The supporting information will be available in january'26 till january'27
• Access Criteria: Other investigators will be able to access to this information by contacting by email with the principal investigator

Locations

ES (1)