Treating alcohol withdrawal with oral baclofen: A randomized, double‐blind, placebo‐controlled trial

Abstract

BACKGROUND:Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS).OBJECTIVE:To determine the effect of the gamma‐aminobutyric acid (GABA)‐B agonist baclofen on the course of acute symptomatic AWS.DESIGN:Prospective, randomized, double‐blind, placebo‐controlled clinical study.SETTING:Two tertiary‐care hospitals in Duluth, Minnesota.PATIENTS:Inpatient adults admitted for any reason (including AWS) judged to be at high risk for AWS.INTERVENTION:Inpatients who developed symptoms of AWS received symptom‐triggered benzodiazepine treatment using lorazepam by standard protocol, and were randomized to receive baclofen 10 mg or placebo, 3 times per day, orally.MEASUREMENTS:AWS severity was assessed using the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA‐Ar); lorazepam dose was monitored.RESULTS:Seventy‐nine subjects were enrolled. The 44 subjects who developed symptoms of AWS were randomized to baclofen or placebo. Thirty‐one subjects (18 baclofen, 13 placebo) completed 72 hours of assessments, either entirely as inpatients or with outpatient follow‐up. The need for high doses of benzodiazepines (20 mg or more of lorazepam over 72 hours) to control AWS was less likely in the baclofen treatment group (1 of 18) than in the placebo‐treated group (7 of 13) (P = 0.004).CONCLUSIONS:We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low‐dose baclofen in the management of AWS deserves further study, as reduced dependence on high‐dose benzodiazepines in AWS management could improve patient safety. Journal of Hospital Medicine 2011;6:474–479. © 2011 Society of Hospital Medicine

Efficacy and Tolerability of Baclofen in Substance Use Disorders: A Systematic Review

“…Despite the positive results obtained in this single study, evidence for recommending baclofen in the treatment of AWS was considered insufficient by the authors of the review. A subsequent RCT confirmed the effectiveness of baclofen compared to placebo in reducing the intensity of AWS [83]. Namely, this study, in which all subjects received symptom-triggered benzodiazepines, found that baclofen reduced the use of benzodiazepines in the management of AWS over 72 h of observation (table 2).…”

“…In fact, these articles described 11 RCTs because 2 of them referred to the same RCT [76,77]. In detail, 4 RCTs were on AUDs [73,74,75,80], 2 RCTs were on the treatment of withdrawal from alcohol or other substances [76,77,83], 2 RCTs were on the treatment of CUDs [82,84], 1 RCT was on the treatment of opioid use disorders [78], 1 RCT was on the treatment of nicotine use disorders (NUDs) [79] and the last RCT was on the treatment of methamphetamine use disorders [81]. Details of these RCTs are shown in tables 1, 2, 3.…”

“…Overall, 52 articles were assessed. Among them, 12 articles were selected as they specifically referred to RCTs [73,74,75,76,77,78,79,80,81,82,83,84]. In fact, these articles described 11 RCTs because 2 of them referred to the same RCT [76,77].…”

“…Among the other 7 RCTs, 3 studies found that baclofen is effective in the treatment of alcohol withdrawal syndrome (AWS; 1 study out of 1) [83], heroin withdrawal syndrome (1 study out of 1) [76,77] and NUDs (1 study out of 1) [79], whilst 4 studies found it to be ineffective in the treatment of CUDs (2 studies out of 2) [82,84], opioid use disorders (1 study out of 1) [78] and methamphetamine use disorders (1 study out of 1) [81]. All the RCTs showed that baclofen is devoid of particularly serious side effects, except 2 studies in which 4 patients experienced adverse effects requiring hospitalization [82,84]; however, in one of them, 2 patients from the placebo group also required hospitalization because of side effects [82].…”

Psychiatric Emergencies for Clinicians: Emergency Department Management of Alcohol Withdrawal

“…Carbamazepine and gabapentin have proven comparable to benzodiazepines in several studies (29,30). Valproic acid and baclofen have been used adjunctively to decrease the administration of benzodiazepines and improve subjective withdrawal symptoms (31,32). A single dose of the older anticonvulsant phenobarbital in the ED may improve outcomes and facilitate outpatient detoxification (33,34).…”