Oral baclofen in the management of alcohol withdrawal: A randomized, double-blind, placebo-controlled trial

Background: Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). Inpatients at risk for AWS are usually treated with benzodiazepine regimens, but high benzodiazepine doses can cause substantial morbidity and prolonged hospitalizations. The current study was designed to examine the effect of baclofen on AWS symptoms and on benzodiazepine doses. Study Design: This was a prospective, double-blind, randomized, placebo-controlled study. Inpatients were enrolled if they were at risk for AWS, and able to provide informed consent. Enrolled subjects who developed symptoms of AWS were randomized to receive either baclofen 10mg or placebo three times per day, in addition to standard benzodiazepine therapy for AWS. AWS severity was assessed at baseline and throughout the 72-hour observation period using the Clinical Institute Withdrawal Assessment for Withdrawal for Alcohol (CIWA-Ar). Results: Seventy-nine subjects provided informed consent and were enrolled in the study. The forty-four subjects who developed symptoms of AWS were randomized to baclofen or placebo. Thirty-one subjects (18 baclofen, 13 placebo) completed 72 hours of assessments CIWA-Ar. The use of high doses of benzodiazepines (20mg or more of lorazepam over 72 hours) to control AWS was less likely in subjects who received baclofen (1 of 18) than in subjects who received placebo (7 of 13) (p=0.004). Conclusions: Baclofen continues to show promise in the management of AWS. Baclofen may be considered for use as an adjunct to standard therapy. If confirmed by further research, baclofen may effectively replace benzodiazepine therapy for AWS in some patients.