EFFICACY AND SAFETY OF HIGH-DOSE BACLOFEN FOR THE TREATMENT OF ALCOHOL DEPENDENCE: A MULTICENTRE, RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL

Sandra HelinskiLeave a Comment

Beraha EM1, Salemink E*1, Goudriaan AE*2,3,4, Bakker A8, de Jong D1, Smits N5, Zwart JW5, van Geest D6, Bodewits P7, Schiphof T6, Defourny H5, van Tricht M2, van den Brink W**2,3, Wiers RW**1

* Shared second authorship
** Shared senior authorship

1University of Amsterdam, Amsterdam, The Netherlands
2Academical Medical Centre (AMC), Amsterdam, The Netherlands
3Amsterdam Institute for Addiction Research, Amsterdam, The Netherlands
4Arkin Institute for Mental Health Care, Amsterdam, The Netherlands
5SolutionS Center, Voorthuizen, The Netherlands
6U-Center, Epen, The Netherlands
7The Home Clinic, Weesp, The Netherlands
8RoderSana Addiction Treatment, Oirschot, The Netherlands

Previous Randomised Controlled Trials (RCTs) with low-to-medium doses of baclofen (30-60 mg) showed inconsistent results, but case studies suggested a dose-response effect and positive outcomes in patients on high doses of baclofen (up to 270 mg). Its prescription was temporary permitted for the treatment of AD in France, and baclofen is now widely prescribed. Recently, a small RCT found a strong effect of a mean dose of 180 mg baclofen. In the present study the efficacy and safety of high doses of baclofen was examined in a multi-centre, double-blind, placebo-controlled trial. 151 patients were randomly assigned to either six weeks titration and ten weeks high-dose baclofen (N=58; up to 150 mg), low-dose baclofen (N=31; 30 mg), or placebo (N=62). Primary outcome measure was time to first relapse. Results will be presented.

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