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.

This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

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