BASIS trial
Research type
Research Study
Full title
An Adaptive-Design Randomised Placebo-Controlled Trial of Baclofen in the Treatment of Alcohol Use Disorder in Patients with Liver Cirrhosis
IRAS ID
1006141
Contact name
Paul Richardson
Contact email
Sponsor organisation
Liverpool University Hospitals NHS Foundation Trust
Eudract number
2022-000154-28
Research summary
Continued alcohol consumption in the presence of cirrhosis accelerates the time to death. Baclofen has been considered as a promising alcohol anti-craving agent in the treatment of Alcohol Use Disorder (AUD). In patients with alcohol-related liver cirrhosis, stopping alcohol consumption (abstinence) can lead to improvements in how the liver works, resulting in longer life expectancy. Therefore, helping people to stop drinking is the most important aim of treatment. Our proposed trial will evaluate 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. Participants will be recruited from secondary care settings within NHS trusts with the trial population reflecting the range of disease severity, co-morbidities, and social and ethnic groups encountered in everyday clinical practice.
The patients will be aged 18-75 years. We will include a 2-week run-in period to identify participants who do not wish to change their drinking behaviour at this time. Participants will be randomised after the run-in period to one of the four treatment arms using double-blind methods, meaning neither the participants nor the site doctors and nurses will know which treatment has been allocated. We will also undertake blood sampling 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.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0006
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion