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description Publicationkeyboard_double_arrow_right Article , Other literature type 2022 Italy, France, Italy, ItalyPublisher:SAGE Publications Authors: Guiraud, Julien; Addolorato, Giovanni; Antonelli, Mariangela; Aubin, Henri-Jean; +29 AuthorsGuiraud, Julien; Addolorato, Giovanni; Antonelli, Mariangela; Aubin, Henri-Jean; de Bejczy, Andrea; Benyamina, Amine; Cacciaglia, Roberto; Caputo, Fabio; Dematteis, Maurice; Ferrulli, Anna; Goudriaan, Anna; Gual, Antoni; Lesch, Otto-Michael; Maremmani, Icro; Mirijello, Antonio; Nutt, David; Paille, François; Perney, Pascal; Poulnais, Roch; Raffaillac, Quentin; Rehm, Jürgen; Rolland, Benjamin; Rotondo, Claudia; Scherrer, Bruno; Simon, Nicolas; Skala, Katrin; Söderpalm, Bo; Somaini, Lorenzo; Sommer, Wolfgang; Spanagel, Rainer; Vassallo, Gabriele; Walter, Henriette; van den Brink, Wim;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
Archivio istituziona... arrow_drop_down Université Grenoble Alpes: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université Jean Monnet – Saint-Etienne: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)add ClaimPlease grant OpenAIRE to access and update your ORCID works.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.All Research productsarrow_drop_down <script type="text/javascript"> <!-- document.write('<div id="oa_widget"></div>'); document.write('<script type="text/javascript" src="https://beta.openaire.eu/index.php?option=com_openaire&view=widget&format=raw&projectId=10.1177/02698811221104063&type=result"></script>'); --> </script>For further information contact us at helpdesk@openaire.euAccess RoutesGreen hybrid 12 citations 12 popularity Top 10% influence Average impulse Top 10% 
Powered by BIP!more_vert Archivio istituziona... arrow_drop_down Université Grenoble Alpes: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université Jean Monnet – Saint-Etienne: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)add ClaimPlease grant OpenAIRE to access and update your ORCID works.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.All Research productsarrow_drop_down <script type="text/javascript"> <!-- document.write('<div id="oa_widget"></div>'); document.write('<script type="text/javascript" src="https://beta.openaire.eu/index.php?option=com_openaire&view=widget&format=raw&projectId=10.1177/02698811221104063&type=result"></script>'); --> </script>For further information contact us at helpdesk@openaire.eu
description Publicationkeyboard_double_arrow_right Article , Other literature type 2022 Italy, France, Italy, ItalyPublisher:SAGE Publications Authors: Guiraud, Julien; Addolorato, Giovanni; Antonelli, Mariangela; Aubin, Henri-Jean; +29 AuthorsGuiraud, Julien; Addolorato, Giovanni; Antonelli, Mariangela; Aubin, Henri-Jean; de Bejczy, Andrea; Benyamina, Amine; Cacciaglia, Roberto; Caputo, Fabio; Dematteis, Maurice; Ferrulli, Anna; Goudriaan, Anna; Gual, Antoni; Lesch, Otto-Michael; Maremmani, Icro; Mirijello, Antonio; Nutt, David; Paille, François; Perney, Pascal; Poulnais, Roch; Raffaillac, Quentin; Rehm, Jürgen; Rolland, Benjamin; Rotondo, Claudia; Scherrer, Bruno; Simon, Nicolas; Skala, Katrin; Söderpalm, Bo; Somaini, Lorenzo; Sommer, Wolfgang; Spanagel, Rainer; Vassallo, Gabriele; Walter, Henriette; van den Brink, Wim;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
Archivio istituziona... arrow_drop_down Université Grenoble Alpes: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université Jean Monnet – Saint-Etienne: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)add ClaimPlease grant OpenAIRE to access and update your ORCID works.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.All Research productsarrow_drop_down <script type="text/javascript"> <!-- document.write('<div id="oa_widget"></div>'); document.write('<script type="text/javascript" src="https://beta.openaire.eu/index.php?option=com_openaire&view=widget&format=raw&projectId=10.1177/02698811221104063&type=result"></script>'); --> </script>For further information contact us at helpdesk@openaire.euAccess RoutesGreen hybrid 12 citations 12 popularity Top 10% influence Average impulse Top 10% Powered by BIP!more_vert Archivio istituziona... arrow_drop_down Université Grenoble Alpes: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)Université Jean Monnet – Saint-Etienne: HALArticle . 2022Full-Text: https://inserm.hal.science/inserm-04057658Data sources: Bielefeld Academic Search Engine (BASE)add ClaimPlease grant OpenAIRE to access and update your ORCID works.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.This Research product is the result of merged Research products in OpenAIRE.
You have already added works in your ORCID record related to the merged Research product.All Research productsarrow_drop_down <script type="text/javascript"> <!-- document.write('<div id="oa_widget"></div>'); document.write('<script type="text/javascript" src="https://beta.openaire.eu/index.php?option=com_openaire&view=widget&format=raw&projectId=10.1177/02698811221104063&type=result"></script>'); --> </script>For further information contact us at helpdesk@openaire.eu