High-Dose Baclofen for the Treatment of Alcohol Dependence (BACLAD study): A Randomized, Placebo-Controlled Trial
Christian A. M?_llera, , , Olga Geisela, Patricia Pelza, Verena Higla, Josephine Kr?_gera, Anna Stickela, Anne Becka, Klaus-Dieter Werneckeb, Rainer Hellwega, Andreas Heinza
Abstract
Previous randomized, placebo-controlled trials (RCTs) assessing the efficacy of the selective γ-aminobutyric acid (GABA)-B receptor agonist baclofen in the treatment of alcohol dependence have reported divergent results, possibly related to the low to medium dosages of baclofen used in these studies (30???80 mg/d). Based on preclinical observations of a dose-dependent effect and positive case reports in alcohol-dependent patients, the present RCT aimed to assess the efficacy and safety of individually titrated high-dose baclofen for the treatment of alcohol dependence. Out of 93 alcohol-dependent patients consecutively screened, 56 were randomly assigned to a double-blind treatment with individually titrated baclofen or placebo using dosages of 30???270 mg/d. The multiple primary outcome measures were 1) total abstinence and 2) cumulative abstinence duration during a 12-week high-dose phase. More patients of the baclofen group maintained total abstinence during the high-dose phase than those receiving placebo (15/22, 68.2% vs. 5/21, 23.8%, p=0.014). Cumulative abstinence duration was significantly higher in patients given baclofen compared to patients of the placebo group (mean 67.8 (SD 30) vs. 51.8 (SD 29.6) days, p=0.047). No drug-related serious adverse events were observed during the trial. Individually titrated high-dose baclofen effectively supported alcohol-dependent patients in maintaining alcohol abstinence and showed a high tolerability, even in the event of relapse. These results provide further evidence for the potential of baclofen, thereby possibly extending the current pharmacological treatment options in alcohol dependence.
Keywords
Alcohol dependence; Pharmacotherapy; High-dose baclofen
Correspondence to: Department of Psychiatry, Campus Charit? Mitte, Charit? ??? Universit?_tsmedizin Berlin, Charit?platz 1, 10117 Berlin, Germany. Tel.: +49 30 450 617159; fax: +49 30 450 517953.
Copyright ?? 2015 Elsevier B.V. and ECNP. All rights reserved.
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