P.3.012 - Baclofen in managing acute alcohol withdrawal: preliminary findings from a randomised controlled trial

Abstract

Introduction Alcohol-use disorders (AUD) have a high global prevalence and about half of the patients suffering from AUD will develop withdrawal symptoms upon cessation of alcohol intake. Therefore, management of alcohol withdrawal has a significant place in medical care. The current gold standard for the prevention and treatment of the alcohol withdrawal syndrome is the GABA-A agonist diazepam [1]. Because of side-effects like high sedation, risk of respiratory depression, its addictive properties and possible liver impairment, alternative pharmacological treatment options are desirable. Baclofen, a GABA-B agonist prescribed for the treatment of spasticity, seems like a promising agent to act as such an alternative. More recently, its off-label use has found its place in the management of alcohol-use disorder because of its anti-craving properties [2]. Given its effects on the GABA system and it lacking the negative aspects of diazepam, baclofen could be a viable treatment alternative in managing alcohol withdrawal. Promising results from studies by Addolorato and Lyon, included in a recent Cochrane review, substantiate the above claim [3]. Moreover, as baclofen treatment can be continued to counter craving, it can offer a simplification of the pharmacological treatment of alcohol-use disorder as a whole. Goal The current study investigates the use of baclofen compared to placebo in the management of AUD, and additionally explores the possible dose-effect relation of baclofen in reducing alcohol craving. Method A single-blinded randomized placebo-controlled trial is being conducted with three arms (placebo, baclofen 30 mg/day and baclofen 60 mg/day) in 90 treatment-seeking AUD patients, for 7 consecutive days. During the study, patients can receive additional diazepam as-needed by protocol, primarily based on the Clinical Institute Withdrawal Assessment for Alcohol Revised (CIWA-ar) scale score. Assessment takes place every two hours during the first three days, and every four hours during the last four days. The primary outcome measure is the amount of patients who received additional diazepam during these 7 days, analyzed using a Chi-Square test. Secundary outcome measures include the amount of additional diazepam, analyzed with ANOVA. Results So far, 29 patients were included in the study. Fewer patients receiving baclofen 60 mg/dayneeded additional diazepam (2 out of 12) compared to those receiving either baclofen 30 mg/day (3 out of 8) or placebo (6 out of 9), but this did not reach statistical significance (p = 0.061). The mean amount of diazepam needed per patient was 10 mg for placebo, 5 mg for baclofen 30 mg/day and 1.67 mg for baclofen 60 mg/day (p = 0.091). Conclusion These preliminary findings show that baclofen in a dose of 60 mg/day, may be a useful alternative to diazepam in treatment-seeking AUD patients during alcohol withdrawal. Further inclusion of patients will demonstrate if this trend is carried on and if there’s a significant difference to be found.