Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption
NCT ID: NCT06840652
Last Updated: 2025-02-21
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2022-12-22
2026-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Active alcohol consumption
* Use of baclofen for the treatment of alcohol dependence.
Exclusion Criteria
* Organic or functional renal insufficiency
18 Years
75 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Jordi Sanchez-Delgado
Head of the Hepatology Hospitalization Unit
Principal Investigators
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Jordi Sánchez Delgado, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Consorci Corporació Sanitària Parc Taulí
Locations
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Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2023/5106
Identifier Type: OTHER
Identifier Source: secondary_id
2023/5106
Identifier Type: -
Identifier Source: org_study_id
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