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

Официальное название

Safety and Efficacy Assessment of Baclofen for Alcohol Withdrawal in Patients With Chronic Liver Disease and Active Alcohol Consumption

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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 manag

Первичные конечные точки

• Rate of patients who achieve abstinence [Срок оценки: During 6 months]
• Rate of patients who reduce alcohol consumption [Срок оценки: During 6 months]

Вторичные конечные точки (2)

• Rate of patients discontinuing treatment due to side effects [Срок оценки: During 6 months]
• CHILD and MELD score improvement if abstinence is achieve [Срок оценки: During 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Consorci Corporació Sanitària Parc Taulí — Sabadell

Публикации

• 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 PMID 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. PMID 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. PMID 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, Wil PMID 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. PMID 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. PMID 30146330

Идентификаторы

NCT: NCT06840652 · 2023/5106 · 2023/5106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗