Alcoholic Liver Disease | Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Alcoholic Liver Disease research study
What is the primary objective of this study?
To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.
Who is eligible to participate?
Inclusion Criteria: - ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for >10 years. - Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2) - Adequate cognition and English language skills to give valid consent and complete research interviews - Willingness to give written informed consent - Abstinence from alcohol for between 3 and 21 days - Resolution of any clinically evident alcohol withdrawal (CIWA-AR) Exclusion Criteria: - Active major psychological disorder associated with psychosis or significant suicide risk - Pregnancy or lactation - Concurrent use of any psychotropic medication other than antidepressants - Substance use other than nicotine if unstable - Clinical evidence of persisting hepatic encephalopathy - Pending incarceration - Lack of stable housing - Active peptic ulcers - Unstable diabetes mellitus
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Alcoholic Liver Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Baclofen 30mg/day30mg/day 10 mg t.i.d
Drug:Baclofen 75mg/day75mg/day 25 mg t.i.d
Drug:PlaceboPlacebo 3 matched tabs/day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1Baclofen low dose
Arm 2Baclofen high dose
Start Date: March 2013
Completed Date: June 2017
Phase: Phase 3
Primary Outcome: alcohol consumption
Secondary Outcome: clinical markers of liver injury
Study sponsors, principal investigator, and references
Principal Investigator: Paul S Haber, MBBS
Lead Sponsor: South West Sydney Local Health District
Collaborator: National Health and Medical Research Council, Australia