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Baclofen, FDA approved for treating multiple sclerosis and widely prescribed off label in France for alcohol use disorder (AUD) treatment, was controversially approved in 2018 by France for this purpose, largely based on unpublished study results (Alcohol Alcohol 2019 Nov 25). This pivotal multicenter study has now been published.
Primary-care patients with high-risk alcohol consumption (n=320) were randomized to baclofen (dose titrated to tolerability; maximum, 300 mg/day) or placebo for a year. To mimic the real world, the investigators neither required detoxification nor offered a psychosocial platform; the study's focus was on harm reduction. Participants could switch to open-label baclofen if not improving.
Median maximum dose for baclof…