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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01711125
Study type Interventional
Source South West Sydney Local Health District
Contact
Status Completed
Phase Phase 3
Start date March 2013
Completion date June 2017

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