Overview
Welcome to the BASIS website
An Adaptive-Design Randomised Placebo-Controlled Trial of Baclofen in the Treatment of Alcohol Use Disorder in Patients with Liver Cirrhosis
Randomised patients
Target patients
400
Open sites
3
Target Sites
8
Thank you to the sites and all patients that are taking part!
BASIS is a multi-centre trial looking at the effect of baclofen in the treatment of alcohol use disorder in patients with liver damage.
Baclofen is a medication used to relax the muscles in patients with, for example, spinal cord injuries or multiple sclerosis. However, it has also been shown to get rid of alcohol cravings, but we don’t know which dose of baclofen is best.
The aim of the trial is to look at whether baclofen is an effective treatment option in patients with alcohol-related liver cirrhosis, and which dose(s) is/are safe and effective. This trial will test 3 different doses of baclofen and a placebo (dummy treatment) in patients with alcohol-related cirrhosis over 24 weeks.
The trial is funded by the National Institute for Health Research's Health Technology Assessment Programme (NIHR HTA) and is sponsored by Liverpool University Hospitals NHS Foundation Trust. The day-to-day running of the trial, monitoring and analysis is being coordinated by a team at the Liverpool Clinical Trials Centre (LCTC).
Study Summary
Why are we doing the BASIS study?
Continued alcohol consumption in people diagnosed with cirrhosis quickens the time to death. It follows, that helping people stop drinking (abstinence) can lead to improvements in how the liver works, resulting in longer life expectancy. Baclofen has been identified as a promising alcohol anti-craving medicine with potential to help people to stop drinking which is clearly the most important aim of treatment.
Purpose of research
BASIS will investigate the efficacy and safety of different doses of baclofen compared to placebo in patients with alcohol use disorder.
The results from this study will be used to help improve treatments for patients with alcohol-related liver damage.
What does the study involve?
Participants will be recruited from secondary care settings within NHS trusts with the trial population reflecting the range of disease severity, co-morbidities (co-existing disease), and social and ethnic groups encountered in everyday clinical practice. The patients will be aged 18-65 years.
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 for patients to receive appropriate medical treatment and reduce test anxiety. Patients scoring ‘yes’ to questions 3 or above will be referred for mental health assessment following local standard of care procedures. Results of mental health assessment will determine eligibility (i.e. patient determined to be at risk of suicide will not be eligible for the trial).
Two weeks following registration, participants will be assessed for entry to randomisation. Participants who do not meet the entry criteria will not be randomised.
Participants will be randomised to one of the four treatment arms using double-blind methods, meaning neither the participants or the research doctors and nurses will know which treatment has been allocated:
- Baclofen 10mg
- Baclofen 20mg
- Baclofen 30mg
- Placebo
Blood sampling will also be undertaken to determine the relationship between the amount of baclofen in the bloodstream to and how participants respond. This will help us to identify the best dose for each individual.
Who may be eligible?
Patients aged 18-65 years, with confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification.
Participating Centres
Information for Sites
Link to database/randomisation system
Key information for all sites
Trial Newsletter (to be added)
BASIS Collaborators
Study funder
National Institute for Health and Care Research Health Technology Assessment Programme (NIHR HTA) (NIHR131129)
Study Organiser
Liverpool clinical Trials Centre (LCTC), part of University of Liverpool
Study review and approval
The study has been reviewed by the South Central – Berkshire B Research Ethics Committee, who have agreed that the study is being conducted in a correct and appropriate manner. The study has also been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Key Contacts and Links
For further information about BASIS, please contact:
Telephone
0151 794 0619
Address
Liverpool Clinical Trials CentreBlock C, Waterhouse Building
Brownlow Street
Liverpool
L69 3GL