Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial - Inserm - Institut national de la santé et de la recherche médicale Access content directly
Journal Articles Journal of Psychopharmacology Year : 2022

Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial

1 Amsterdam UMC - Amsterdam University Medical Center
2 UvA - University of Amsterdam [Amsterdam] = Universiteit van Amsterdam
3 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4 CESP - Centre de recherche en épidémiologie et santé des populations
5 Hôpital Paul Brousse
6 GU - Göteborgs Universitet = University of Gothenburg
7 LFCT - Laboratorio Farmaceutico CT [San Remo, Italy]
8 UniFE - Università degli Studi di Ferrara = University of Ferrara
9 UGA - Université Grenoble Alpes
10 IRCCS Ospedale San Raffaele [Milan, Italy]
11 UNIMI - Università degli Studi di Milano = University of Milan
12 Amsterdam School of Public Health [the Netherlands]
13 IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer
14 University of Vienna [Vienna]
15 University of Pisa - Università di Pisa
16 IRCCS - Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Casa Sollievo della Sofferenza [San Giovanni Rotondo]
17 Imperial College London
18 CHU Nancy - Centre Hospitalier Universitaire de Nancy
19 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
20 UM - Université de Montpellier
21 DAPP - D&A Pharma Paris - Laboratoires pharmaceutiques
22 CAMH - Centre for Addiction and Mental Health [Toronto]
23 University of Toronto
24 TU Dresden - Technische Universität Dresden = Dresden University of Technology
25 MSMU - I.M. Sechenov First Moscow State Medical University [Moscow, Russia]
26 CRNL - Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center
27 CRARL - Centro di Riferimento Alcologico della Regione Lazio [Roma, Italy]
28 BSC - Bruno Scherrer Conseil [Saint Arnoult en Yvelines]
29 SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
30 Hôpitaux Sud - Hôpital Sainte-Marguerite [CHU - APHM]
31 Medizinische Universität Wien = Medical University of Vienna
32 ATC - Local Health Unit - Addiction Treatment Center [ASL Biella, Italy]
33 Universität Heidelberg [Heidelberg] = Heidelberg University
34 BLH - Barone Lombardo Hospital [Canicattì, Italy]
35 Amsterdam UMC - Amsterdam University Medical Centers

Abstract

Background: Sodium oxybate (SMO) has been shown to be effective in the maintenance of abstinence (MoA) in alcohol-dependent patients in a series of small randomized controlled trials (RCTs). These results needed to be confirmed by a large trial investigating the treatment effect and its sustainability after medication discontinuation. Aims: To confirm the SMO effect on (sustained) MoA in detoxified alcohol-dependent patients. Methods: Large double-blind, randomized, placebo-controlled trial in detoxified adult alcohol-dependent outpatients (80% men) from 11 sites in four European countries. Patients were randomized to 6 months SMO (3.3–3.9 g/day) or placebo followed by a 6-month medication-free period. Primary outcome was the cumulative abstinence duration (CAD) during the 6-month treatment period defined as the number of days with no alcohol use. Secondary outcomes included CAD during the 12-month study period. Results: Of the 314 alcohol-dependent patients randomized, 154 received SMO and 160 received placebo. Based on the pre-specified fixed-effect two-way analysis of variance including the treatment-by-site interaction, SMO showed efficacy in CAD during the 6-month treatment period: mean difference +43.1 days, 95% confidence interval (17.6–68.5; p = 0.001). Since significant heterogeneity of effect across sites and unequal sample sizes among sites ( n = 3–66) were identified, a site-level random meta-analysis was performed with results supporting the pre-specified analysis: mean difference +32.4 days, p = 0.014. The SMO effect was sustained during the medication-free follow-up period. SMO was well-tolerated. Conclusions: Results of this large RCT in alcohol-dependent patients demonstrated a significant and clinically relevant sustained effect of SMO on CAD. Trial registration: ClinicalTrials.gov Identifier: NCT04648423
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inserm-04057658 , version 1 (04-04-2023)

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Julien Guiraud, Giovanni Addolorato, Mariangela Antonelli, Henri-Jean Aubin, Andrea de Bejczy, et al.. Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial. Journal of Psychopharmacology, 2022, 36 (10), pp.1136-1145. ⟨10.1177/02698811221104063⟩. ⟨inserm-04057658⟩
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