Dataset Information

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

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.

SUBMITTER: Guiraud J

PROVIDER: S-EPMC9548946 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Guiraud Julien J Addolorato Giovanni G Antonelli Mariangela M Aubin Henri-Jean HJ de Bejczy Andrea A Benyamina Amine A Cacciaglia Roberto R Caputo Fabio F Dematteis Maurice M Ferrulli Anna A Goudriaan Anna E AE Gual Antoni A Lesch Otto-Michael OM Maremmani Icro I Mirijello Antonio A Nutt David J DJ Paille François F Perney Pascal P Poulnais Roch R Raffaillac Quentin Q Rehm Jürgen J Rolland Benjamin B Rotondo Claudia C Scherrer Bruno B Simon Nicolas N Skala Katrin K Söderpalm Bo B Somaini Lorenzo L Sommer Wolfgang H WH Spanagel Rainer R Vassallo Gabriele A GA Walter Henriette H van den Brink Wim W

Journal of psychopharmacology (Oxford, England) 20220707 10

<h4>Background</h4>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.<h4>Aims</h4>To confirm the SMO effect on (sustained) MoA in detoxified alcohol-dependent patients.<h4>Methods</h4>Large double-blind, randomized, placebo-co ...[more]

PMID: 35796481

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Dataset Information

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

Background

Aims

Methods

Results

Conclusions

Trial registration

Publications

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

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