K C Morley1, A Baillie2, S Leung3, G Addolorato4, L Leggio5, P S Haber6. 1. NHMRC Centre of Research Excellence in Mental Health and Substance Use, Discipline of Addiction Medicine, University of Sydney, Sydney, NSW, Australia kirsten.morley@sydney.edu.au. 2. NHMRC Centre of Research Excellence in Mental Health and Substance Use, Department of Psychology, Macquarie University, Sydney, NSW, Australia. 3. Central Clinical School, University of Sydney, Sydney, NSW, Australia. 4. Institute of Internal Medicine, Catholic University of Rome, Rome, Italy. 5. Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. 6. NHMRC Centre of Research Excellence in Mental Health and Substance Use, Discipline of Addiction Medicine, University of Sydney, Sydney, NSW, Australia Drug Health Services, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
Abstract
AIM: To conduct a double-blind, placebo-controlled randomized clinical trial of baclofen in the treatment of alcohol dependence. METHODS: Out of 69 participants consecutively screened, 42 alcohol-dependent patients were randomized to receive placebo, baclofen 30 mg/day or baclofen 60 mg/day for 12 weeks. All subjects were offered BRENDA, a structured psychosocial therapy for alcohol dependence that seeks to improve motivation for change, enhance strategies to prevent relapse and encourage compliance with treatment. RESULTS: Intention-to-treat analyses revealed that alcohol consumption (heavy drinking days, drinks per drinking day) significantly reduced across all three groups during the treatment period. There were no statistically significant advantages to treatment on time to first heavy drinking day (relapse) (P = 0.08), nor time to first drink (lapse) (P = 0.18). A post hoc analysis stratifying according to whether there had been a comorbid anxiety disorder, revealed a beneficial effect of baclofen 30 mg/day versus placebo on time to lapse and relapse (P < 0.05). There was also a beneficial effect for baclofen 60 mg/day relative to placebo on time to relapse in this comorbid group (P < 0.05). Both doses of baclofen were well tolerated. There were no serious adverse events. CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study suggests a specific role of baclofen in alcohol-dependent individuals with comorbid anxiety. Replication in larger, fully-powered studies is required.
RCT Entities:
AIM: To conduct a double-blind, placebo-controlled randomized clinical trial of baclofen in the treatment of alcohol dependence. METHODS: Out of 69 participants consecutively screened, 42 alcohol-dependent patients were randomized to receive placebo, baclofen 30 mg/day or baclofen 60 mg/day for 12 weeks. All subjects were offered BRENDA, a structured psychosocial therapy for alcohol dependence that seeks to improve motivation for change, enhance strategies to prevent relapse and encourage compliance with treatment. RESULTS: Intention-to-treat analyses revealed that alcohol consumption (heavy drinking days, drinks per drinking day) significantly reduced across all three groups during the treatment period. There were no statistically significant advantages to treatment on time to first heavy drinking day (relapse) (P = 0.08), nor time to first drink (lapse) (P = 0.18). A post hoc analysis stratifying according to whether there had been a comorbid anxiety disorder, revealed a beneficial effect of baclofen 30 mg/day versus placebo on time to lapse and relapse (P < 0.05). There was also a beneficial effect for baclofen 60 mg/day relative to placebo on time to relapse in this comorbid group (P < 0.05). Both doses of baclofen were well tolerated. There were no serious adverse events. CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study suggests a specific role of baclofen in alcohol-dependent individuals with comorbid anxiety. Replication in larger, fully-powered studies is required.
Authors: James C Garbutt; Alexei B Kampov-Polevoy; Robert Gallop; Linda Kalka-Juhl; Barbara A Flannery Journal: Alcohol Clin Exp Res Date: 2010-11 Impact factor: 3.455
Authors: Mary-Anne Enoch; Colin A Hodgkinson; Pei-Hong Shen; Elena Gorodetsky; Cheryl A Marietta; Alec Roy; David Goldman Journal: Alcohol Clin Exp Res Date: 2016-01 Impact factor: 3.455