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Alcoholic CirrhosisBAWICNCT06840652

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

An observational study of Alcoholic Cirrhosis and Alcohol Abstinence, run by Corporacion Parc Tauli at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Baclofen
How many people
120 participants
Where
1 siteSpain
Study dates
22 Dec 2022to Jul 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

  • Consorci Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

Official title: 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.

Read the 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

Being tested
Baclofen
Keywords
alcohol withdrawal, baclofen, alcoholic cirrhosis, alcohol abstinence
Medical subject headings
Liver Cirrhosis, Alcoholic, Alcohol Abstinence, Drug-Related Side Effects and Adverse Reactions, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaclofenDrug

    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

Study groups in NCT06840652
Study groupRoleWhat they receive
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.
Receives: Drug: Baclofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients who achieve abstinence

    The investigators will report, through clinical interviews, the percentage of patients who have stopped drinking

    Measured: During 6 months

  2. Rate of patients who reduce alcohol consumption

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

    Measured: During 6 months

Secondary outcomes (2)

  1. Rate of patients discontinuing treatment due to side effects

    The investigators will report, through clinical interviews, the tolerance and side effects of the baclofen

    Measured: During 6 months

  2. CHILD and MELD score improvement if abstinence is achieve

    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.

    Measured: During 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start22 Dec 2022
  3. Primary completionJan 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840652
Sponsor's protocol ID
2023/5106
Other IDs
2023/5106
Acronym
BAWIC
Status last verified
Feb 2025
First submitted
11 Jan 2025
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will share our preliminary results with other interested researchers in case they are interested in conducting a multicenter study

Publications

  • 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.

    PubMed 30413394

  • 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.

    PubMed 37441998

  • 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.

    PubMed 33245581

  • 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.

    PubMed 31865172

  • 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.

    PubMed 19560604

  • 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.

    PubMed 30146330

Questions about this trial

What is this clinical trial studying?

An observational study of Alcoholic Cirrhosis and Alcohol Abstinence, run by Corporacion Parc Tauli at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients who achieve abstinence (time frame: During 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840652, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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