Clinical trial NCT06840652: Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption
Official title: Safety and Efficacy Assessment of Baclofen for Alcohol Withdrawal in Patients With Chronic Liver Disease and Active Alcohol Consumption
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alcoholic Cirrhosis
Alcohol Abstinence
Alcohol Withdrawal
Medication Toxicity
Medication Adherence
Keywords: alcohol withdrawal
baclofen
alcoholic cirrhosis
alcohol abstinence
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of patients who achieve abstinence
timeFrame: During 6 months
measure: Rate of patients who reduce alcohol consumption
timeFrame: During 6 months
Secondary outcomes:
measure: Rate of patients discontinuing treatment due to side effects
timeFrame: During 6 months
measure: CHILD and MELD score improvement if abstinence is achieve
timeFrame: During 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Consorci Corporació Sanitària Parc Taulí
name: Jordi Sánchez Delgado, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.