Alcohol Dependence Clinical Trial
Official title:
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
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).
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