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.
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
- Conditions the study is for
- Alcoholic Cirrhosis, Alcohol Abstinence, Alcohol Withdrawal
- 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
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.
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
- Conditions
- Alcoholic Cirrhosis, Alcohol Abstinence, Alcohol Withdrawal, Medication Toxicity, Medication Adherence
- 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 group | Role | What 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.
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
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)
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
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.
- First posted21 Feb 2025
- Study start22 Dec 2022
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Sanchez-Delgado, Corporacion Parc Tauli
- Investigators
- Jordi Sánchez Delgado, MD. PhD, Principal investigator, Consorci Corporació Sanitària Parc Taulí
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 30413394Duan 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 37441998Mekonen 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 33245581Glantz 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 31865172Rehm 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 19560604GBD 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