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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

Alcohol Dependence

Study Interventions

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

Study Arms

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

Arm 3Placebo

Study Status

Completed

Start Date: March 2013

Completed Date: June 2017

Phase: Phase 3

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT01711125

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