Purpose: Few medications are approved for the treatment of alcohol dependence. Is drug therapy with baclofen in the high-dose range a suitable alternative?
Background: Initial larger studies showed contrasting results regarding the efficacy of low-dose baclofen (30 mg/d). However, case reports with high-dose baclofen (up to 270 mg/d) suggest a dose-dependent effect. In 2015, the BACLAD study showed an effective effect of high-dose treatment [1]. The aim of a Dutch study was to test the efficacy of low- and high-dose baclofen and the dose-response relationship [2].
PATIENTS AND METHODS: In the double-blind multicenter study, 151 patients were randomized to receive high-dose baclofen (up to 150 mg), low-dose baclofen (30 mg), or placebo for four months. In the high-dose group, titration of baclofen took place during the first six weeks. The primary endpoint of the study was relapse rate.
Results: Over the complete medication period and in the 10 weeks after the titration phase, there were no differences in relapse rates among the three groups. After the titration phase, 27.5% of patients in the high-dose group, 20% in the low-dose group, and 25% in the placebo group had a relapse. Similar results are found over the full medication period with 50% relapses in the high-dose group, 48.4% in the low-dose group, and 46.8% in the placebo group.
CONCLUSION: Neither low-dose nor high-dose baclofen was shown to be effective. However, only 15% of patients in the high-dose group reached the target dose (mean: 94 mg/d). Compared with the BACLAD study (180 mg/d), this means that the dose achieved is almost half as high. Relapsed patients in the high-dose group achieved a lower dose (84.4 mg/d) than abstinent patients (102.4 mg, p=0.02). In contrast, a post-hoc analysis showed no difference between patients receiving a minimum dose of 120 mg/d and the placebo group.
- Muller, C.A., et al: High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial. Eur Neuropsychopharmacol, 2015. 25(8): 1167-77.
- Beraha, E.M., et al: Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: A multicentre, randomised, double-blind controlled trial. Eur Neuropsychopharmacol, 2016. 26(12): p. 1950-1959.
InFo NEUROLOGY & PSYCHIATRY 2017; 15(2): 24-26.
