title: Sodium oxybate in the treatment of alcohol withdrawal syndrome: a randomized double-blind comparative study versus oxazepam. The GATE 1 trial.
abstract: BACKGROUND
  Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. The aim of this phase IV, multicenter, randomized, double-blind, double-dummy study was to evaluate the efficacy of SMO in comparison with oxazepam in the treatment of uncomplicated AWS.
  
  
  METHODS
  Alcohol-dependent outpatients (n = 126) affected by uncomplicated AWS according to the Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale were enrolled in the study and randomized in two groups: 61 patients received SMO and 65 patients received oxazepam for 10 days. The primary endpoint was the reduction of symptoms of AWS measured by the change in the total CIWA-Ar score from baseline (day 1) to the end of the study (day 10). This study is registered with ClinicalTrials.gov, number: NCT02090504 RESULTS: A significant decrease of the mean total CIWA-Ar score from baseline to the end of the study was found in both the SMO (p < 0.0001) and the oxazepam group (p < 0.0001), with no significant differences between the two treatments (p = 0.21). Treatment with SMO and oxazepam resulted in a marked decrease in the severity of the mean CIWA subscales, i.e. sweating, tremor, and anxiety, with no significant differences between the two treatments. Both drugs were well tolerated and no severe side effects were reported.
  
  
  CONCLUSIONS
  SMO is as effective as oxazepam, one of the gold standard BDZs, in the treatment of uncomplicated AWS. Due to its tolerability and absence of significant side effects, SMO may be considered a valid alternative choice in the treatment of AWS.
authors.affiliation: Department of Internal Medicine, SS Annunziata Hospital, Cento, Ferrara, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Caputo
authors.forename: Katrin
authors.initials: K
authors.lastname: Skala
authors.forename: Antonio
authors.initials: A
authors.lastname: Mirijello
authors.forename: Anna
authors.initials: A
authors.lastname: Ferrulli
authors.forename: Henriette
authors.initials: H
authors.lastname: Walter
authors.forename: Otto
authors.initials: O
authors.lastname: Lesch
authors.forename: Giovanni
authors.initials: G
authors.lastname: Addolorato
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000150:complications*; D001007:Anxiety / Q000188:drug therapy / Q000503:physiopathology; D066249:Craving / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010076:Oxazepam / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012978:Sodium Oxybate / Q000009:adverse effects / Q000627:therapeutic use*; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D011795:Surveys and Questionnaires; D013546:Sweating / Q000187:drug effects; D016896:Treatment Outcome; D014202:Tremor / Q000188:drug therapy / Q000503:physiopathology
chemical_list: D010076:Oxazepam; D012978:Sodium Oxybate