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Cited by 34Alcoholism and Thiamine DeficiencySubstance Abuse Treatment and OutcomesAlcohol Consumption and Health Effects

Sodium oxybate in the treatment of alcohol withdrawal syndrome: A randomized double-blind comparative study versus oxazepam. The GATE 1 Trial

Caputo, Fabio, Skala, Katrin, Mirijello, Antonio, Ferrulli, Anna, Walter, Henriette, Lesch, Otto, Addolorato, Giovanni·2014·CNS Drugs
DOI 10.1007/s40263-014-0183-1
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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.Conclusion 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.

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  • In a study of 126 patients with AUD, both GHB and oxazepam showed significant reduction in AWS symptoms (CIWA-Ar scores) over 10 days, with no significant differences between treatments, and both were well tolerated with no severe side effects.

    “Both groups showed a significant reduction in AWS symptoms (CIWA-Ar scores), with no significant differences between the two treatments. Both GHB and oxazepam were well tolerated, and no severe side effects were reported [46].”

    From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [46]

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Authors
Caputo, F., Skala, K., Mirijello, A., Ferrulli, A., Walter, H., Lesch, O., & Addolorato, G.
Affiliations
  • Medical University of Vienna (AT)
  • Agostino Gemelli University Polyclinic (IT)
Corresponding author
Addolorato, Giovanni
ORCID
Venue
CNS Drugs
Publisher
Springer Science and Business Media LLC
Published
2014-07-05
Volume
28
Issue
8
Pages
743-752
ISSN
  • 1172-7047 (ISSN-L)
  • 1179-1934
DOI
10.1007/s40263-014-0183-1
OpenAlex
W1986297359
Cited by
34
References
33
Citations by year
2026: 2 · 2025: 2 · 2024: 7 · 2023: 4 · 2022: 2 · 2021: 1 · 2020: 4 · 2019: 1 · 2018: 3 · 2017: 2 · 2016: 4 · 2015: 2
FWCI
1.74
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • CNS Drugs (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion)
Topics
  • Health Sciences › Medicine › Neurology › Alcoholism and Thiamine Deficiency
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
Keywords
sodium oxybate, alcohol withdrawal, oxazepam, benzodiazepines, alcoholism, CIWA-Ar, treatment efficacy, tolerability, sweating, tremor, anxiety
MeSH terms
Adult, Alcoholism, Anxiety, Double-Blind Method, Female, Humans, Male, Oxazepam, Surveys and Questionnaires, Severity of Illness Index, Sodium Oxybate, Substance Withdrawal Syndrome, Sweating, Tremor, Treatment Outcome, Craving

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