Kirsten C Morley1, Andrew Baillie2, Isabel Fraser1, Ainsley Furneaux-Bate1, Glenys Dore3, Michael Roberts4, Ahmed Abdalla5, Nghi Phung6, Paul S Haber7. 1. NHMRC Centre of Research Excellence in Mental Health and Substance Use,Central Clinical School, Sydney Medical School, University of Sydney,New South Wales,Australia. 2. NHMRC Centre of Research Excellence in Mental Health and Substance Use,Department of Psychology,Macquarie University,New South Wales,Australia. 3. Herbert St Alcohol Clinic,Royal North Shore Hospital,Sydney,New South Wales,Australia. 4. School of Pharmacy and Medical Sciences,University of South Australia,Adelaide and Therapeutics Research Centre,Diamantina Institute,The University of Queensland,Translational Research Institute,Brisbane,Australia. 5. School of Pharmacy and Medical Sciences,University of South Australia,Adelaide,Australia. 6. Centre for Addiction Medicine, Westmead Hospital,Sydney,New South Wales,Australia. 7. Drug Health Services,Royal Prince Alfred Hospital,New South Wales,Australia.
Abstract
BACKGROUND: There are no available medications for the management of alcohol dependence for patients with alcoholic liver disease (ALD).AimsTo conduct a multisite, double blind, placebo-controlled, randomised clinical trial of baclofen in the treatment of alcohol dependence, with or without liver disease (trial registration: ClinicalTrials.gov, NCT01711125). METHOD: Patients (n = 104) were randomised to placebo, baclofen 30 mg/day or 75 mg/day for 12 weeks. Primary outcomes included survival time to lapse (any drinking), relapse (≥5 drinks per day in men and ≥4 in women), and the composite outcome of drinks per drinking day, number of heavy drinking days, and percentage days abstinent. RESULTS: There was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) and relapse (χ2 = 4.62, P<0.05, d = 0.52). A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). There was one serious adverse event (overdose) directly related to medication (75 mg). CONCLUSIONS:Baclofen may be an effective treatment option for patients with ALD. However, given the profile of adverse events, the role for this medication might be best limited to specialist services.Declaration of interestNone.
RCT Entities:
BACKGROUND: There are no available medications for the management of alcohol dependence for patients with alcoholic liver disease (ALD).AimsTo conduct a multisite, double blind, placebo-controlled, randomised clinical trial of baclofen in the treatment of alcohol dependence, with or without liver disease (trial registration: ClinicalTrials.gov, NCT01711125). METHOD:Patients (n = 104) were randomised to placebo, baclofen 30 mg/day or 75 mg/day for 12 weeks. Primary outcomes included survival time to lapse (any drinking), relapse (≥5 drinks per day in men and ≥4 in women), and the composite outcome of drinks per drinking day, number of heavy drinking days, and percentage days abstinent. RESULTS: There was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) and relapse (χ2 = 4.62, P<0.05, d = 0.52). A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). There was one serious adverse event (overdose) directly related to medication (75 mg). CONCLUSIONS:Baclofen may be an effective treatment option for patients with ALD. However, given the profile of adverse events, the role for this medication might be best limited to specialist services.Declaration of interestNone.
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