Reducing the severity of alcohol withdrawal with oral baclofen: a randomized controlled trial

Abstract

Background: Alcohol withdrawal syndrome (AWS) increases the complexity of inpatient medical care. Baclofen has shown promise in previous studies to modulate the symptoms of AWS. Our objective was to determine if baclofen, when added to symptom triggered benzodiazepines, could prevent medical inpatients at risk for AWS from progressing to moderate or severe AWS.Methods: Double Blind, placebo controlled, randomized trial. Trial registered at ClinicalTrials.gov registration ID NCT02052440. Medical inpatients at a University-affiliated, urban public safety net hospital who were at risk for, or with mild, AWS received Baclofen 10 mg or placebo by mouth every 8 h plus usual care. The primary outcome was the percentage of patients progressing to moderate or severe AWS. Secondary outcomes included the difference in the mean AWS assessment scores at 24, 48, and 72 h and peak and total dosages of benzodiazepines.Results: 101 of 166 targeted patients were enrolled. The primary outcome occurred in 13 of 50 (26%) patients receiving baclofen and 16 of 51 (31%) receiving placebo (p = 0.55). Mean cumulative diazepam administered was 66 mg (±51 SD) in the baclofen group and 85 mg (±63) in the placebo group (p = 0.13). Mean highest dose diazepam was 11 mg (±3) in the baclofen group and 12 mg (±7) in the placebo group (p = 0.14).Conclusion: The addition of baclofen to usual care did not result in a significant difference in progression to moderate or severe AWS but we interpret this result with caution given that we did not meet the enrollment goal.Trial registration: ClinicalTrials.gov identifier: NCT02052440.