Alcohol use disorder in patients with liver cirrhosis Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 16/06/2025:
All participants will undergo screening to detect suicidal ideation using the C-SSRS Screen between day 7 and day 10 post registration. This will ensure time fo
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 16/06/2025: At Registration: 1. Age 18 to 75 years 2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification 3. Abstinent from alcohol at the time of registration for between =1 day and <42 days 4. Capacity to provide informed consent At Randomisation: 1. Age 18 to 75 years 2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification 3. Abstinent from alcohol at the time of the baseline/randomisation visit for between =14 days and <56 days 4. Capacity to provide informed consent 5. Women of reproductive potential must have a negative pregnancy test at randomisation and use highly effective contraception for the duration of the treatment period Previous participant inclusion criteria: At Registration: 1. Age 18 to 65 years 2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification 3. Abstinent from alcohol at the time of registration for between =1 day and <42 days 4. Capacity to provide informed consent At Randomisation: 1. Age 18 to 65 years 2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification 3. Abstinent from alcohol at the time of the baseline/randomisation visit for between =14 days and <56 days 4. Capacity to provide informed consent 5. Women of reproductive potential must have a negative pregnancy test at randomisation and use highly effective contraception for the duration of the treatment period
Exclusion criteria
Exclusion criteria: At registration: 1. Planning to become pregnant, is pregnant or breastfeeding 2. Overt hepatic encephalopathy or trans-jugular intrahepatic porto-systemic shunt in situ 3. Severe renal impairment (stage 5 chronic kidney disease and/or current haemodialysis) 4. History of illicit drug use excluding marijuana in the previous 4 weeks 5. Concurrent use of opioid substitution therapy 6. Use of licenced alcohol anti-craving pharmacotherapy (such as acamprosate, disulfiram naltrexone, nalmefene) in previous 12 weeks 7. Use of baclofen for any purpose in previous 12 weeks 8. Peptic ulceration detected by endoscopy within 14 days of registration. 9. Known hypersensitivity to baclofen or structurally related drugs or any other component of the formulation. 10. Poorly controlled major psychiatric disorder such as schizophrenia or bipolar disorder 11. Individuals who have participated in a trial of a medicinal product within 12 weeks preceding registration 12. Poorly controlled epilepsy 13. Rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption 14. Suffering from porphyria At randomisation: 1. Planning to become pregnant, is pregnant or breastfeeding 2. Overt hepatic encephalopathy or trans-jugular intrahepatic porto-systemic shunt in situ 3. Severe renal impairment (stage 5 chronic kidney disease and/or current haemodialysis) 4. History of illicit drug use excluding marijuana in the previous 6 weeks 5. Concurrent use of opioid substitution therapy, or use in the previous 14 days 6. Use of licenced alcohol anti-craving pharmacotherapy (such as acamprosate, disulfiram naltrexone, nalmefene) in previous 14 weeks 7. Use of baclofen for any purpose in previous 14 weeks 8. Peptic ulceration detected by endoscopy within 28 days of the baseline/randomisation visit. 9. Known hypersensitivity to baclofen or structurally related drugs or any other component of the formulation 10. Scored 3 or more on the C-SSRS Screen and has been assessed by an appropriately qualified mental health practitioner as having suicidal ideation or behaviour prior to the baseline/randomisation visit 11. Poorly controlled major psychiatric disorder such as schizophrenia or bipolar disorder 12. Individuals who have participated in a trial of a medicinal product within 14 weeks preceding the baseline/ randomisation visit 13. Poorly controlled epilepsy 14. Rare hereditary problems of galactose intolerance, total lactose deficiency or glucosegalactose malabsorption 15. Suffering from porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continued abstinence post randomisation for 24 weeks measured using Timeline Followback | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/06/2025: At baseline and weeks 4, 8, 16 and 24 of follow-up unless noted otherwise: 1. Self-reported alcohol consumption since previous visit via Timeline Followback to measure: 1.1. Average units per drinking day 1.2. Percent days abstinent. 1.3. Number of heavy drinking days. 2. Changes in alcohol usage and dependency questionnaires (AUDIT, SADQ, APQ). SADQ to be completed at baseline and if required at follow up, when triggered by Timeline Followback and participant is drinking again. 3. Time to lapse (time to first alcoholic drink) measured using Timeline Followback. 4. Time to relapse (defined as time to consumption of =5 units for women, =6 units for men in a single day) measured using Timeline Followback. 5. Biological markers of alcohol consumption and liver function measured by: 5.1. Ethyl glucuronide test in urine using dipstick at baseline, weeks 1, 2, 4, 8, 16 and 24 of follow-up 5.2. Breath alcohol at baseline, weeks 1, 2, 4, 8, 16 and 24 of follow-up 5.3. LFTs at baseline, weeks 4, 8, 16 and 24 of follow-up 6. Delta changes in liver function as per Child-Pugh and Model of End Stage Liver Disease (MELD-Na) 7. Alcohol craving by Penn Alcohol Craving Scale (PACS) 8. Subsequent hospital attendances and admissions (including unplanned use) at weeks 4, 8, 16 and 24 of follow-up 9. Rate of survival at time of data analysis using median duration of follow-up, ONS data clarification that death data may be requested at the final analysis if required 10. Medication adherence (pill count) at weeks 1, 2, 4, 8, 16 and 24 of follow-up 11. Blood sampling to determine a population pharmacokinetic model for baclofen in patients with alcohol-related liver cirrhosis 12. Recording and assessment of related adverse events at baseline and weeks 1, 2, 4, 8, 16 and 24 of follow-up Previous secondary outcome measures: At baseline and weeks 4, 8, 16 and 24 of follow-up unless noted otherwise: 1. Self-reported alcohol consumption since | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactBASIS Trial Team
Outcome results
None listed