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

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 sustainabili...

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Main Authors: Guiraud, Julien (Author) , Addolorato, Giovanni (Author) , Antonelli, Mariangela (Author) , Aubin, Henri-Jean (Author) , de Bejczy, Andrea (Author) , Benyamina, Amine (Author) , Cacciaglia, Roberto (Author) , Caputo, Fabio (Author) , Dematteis, Maurice (Author) , Ferrulli, Anna (Author) , Goudriaan, Anna E (Author) , Gual, Antoni (Author) , Lesch, Otto-Michael (Author) , Maremmani, Icro (Author) , Mirijello, Antonio (Author) , Nutt, David J (Author) , Paille, François (Author) , Perney, Pascal (Author) , Poulnais, Roch (Author) , Raffaillac, Quentin (Author) , Rehm, Jürgen (Author) , Rolland, Benjamin (Author) , Rotondo, Claudia (Author) , Scherrer, Bruno (Author) , Simon, Nicolas (Author) , Skala, Katrin (Author) , Söderpalm, Bo (Author) , Somaini, Lorenzo (Author) , Sommer, Wolfgang H. (Author) , Spanagel, Rainer (Author) , Vassallo, Gabriele A (Author) , Walter, Henriette (Author) , van den Brink, Wim (Author)
Format: Article (Journal)
Language:English
Published: July 7, 2022
In: Journal of psychopharmacology
Year: 2022, Volume: 36, Issue: 10, Pages: 1136-1145
ISSN:1461-7285
DOI:10.1177/02698811221104063
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1177/02698811221104063
Verlag, kostenfrei, Volltext: https://journals.sagepub.com/doi/full/10.1177/02698811221104063
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Author Notes:Julien Guiraud, Giovanni Addolorato, Mariangela Antonelli, Henri-Jean Aubin, Andrea de Bejczy, Amine Benyamina, Roberto Cacciaglia, Fabio Caputo, Maurice Dematteis, Anna Ferrulli, Anna E Goudriaan, Antoni Gual, Otto-Michael Lesch, Icro Maremmani, Antonio Mirijello, David J Nutt, François Paille, Pascal Perney, Roch Poulnais, Quentin Raffaillac, Jürgen Rehm, Benjamin Rolland, Claudia Rotondo, Bruno Scherrer, Nicolas Simon, Katrin Skala, Bo Söderpalm, Lorenzo Somaini, Wolfgang H Sommer, Rainer Spanagel, Gabriele A Vassallo, Henriette Walter and Wim van den Brink
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Summary: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
Item Description:Gesehen am 08.08.2023
Physical Description:Online Resource
ISSN:1461-7285
DOI:10.1177/02698811221104063

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