Trial exploring the benefits of different doses of baclofen for patients with alcohol addictio
- Conditions
- Alcohol use disorder in patients with liver cirrhosisMental and Behavioural Disorders
- Registration Number
- ISRCTN17435333
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 400
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Continued abstinence post randomisation for 24 weeks measured using Timeline Followback
- Secondary Outcome Measures
Name Time Method