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| Verfasst von: | Guiraud, Julien [VerfasserIn]  |
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| | Addolorato, Giovanni [VerfasserIn] |
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| | Antonelli, Mariangela [VerfasserIn] |
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| | Aubin, Henri-Jean [VerfasserIn] |
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| | de Bejczy, Andrea [VerfasserIn] |
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| | Benyamina, Amine [VerfasserIn] |
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| | Cacciaglia, Roberto [VerfasserIn] |
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| | Caputo, Fabio [VerfasserIn] |
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| | Dematteis, Maurice [VerfasserIn] |
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| | Ferrulli, Anna [VerfasserIn] |
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| | Goudriaan, Anna E [VerfasserIn] |
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| | Gual, Antoni [VerfasserIn] |
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| | Lesch, Otto-Michael [VerfasserIn] |
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| | Maremmani, Icro [VerfasserIn] |
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| | Mirijello, Antonio [VerfasserIn] |
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| | Nutt, David J [VerfasserIn] |
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| | Paille, François [VerfasserIn] |
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| | Perney, Pascal [VerfasserIn] |
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| | Poulnais, Roch [VerfasserIn] |
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| | Raffaillac, Quentin [VerfasserIn] |
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| | Rehm, Jürgen [VerfasserIn] |
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| | Rolland, Benjamin [VerfasserIn] |
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| | Rotondo, Claudia [VerfasserIn] |
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| | Scherrer, Bruno [VerfasserIn] |
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| | Simon, Nicolas [VerfasserIn] |
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| | Skala, Katrin [VerfasserIn] |
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| | Söderpalm, Bo [VerfasserIn] |
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| | Somaini, Lorenzo [VerfasserIn] |
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| | Sommer, Wolfgang H. [VerfasserIn] |
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| | Spanagel, Rainer [VerfasserIn] |
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| | Vassallo, Gabriele A [VerfasserIn] |
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| | Walter, Henriette [VerfasserIn] |
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| | van den Brink, Wim [VerfasserIn] |
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| Titel: | Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients |
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| Titelzusatz: | an international, multicenter, randomized, double-blind, placebo-controlled trial |
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| Verf.angabe: | 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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| E-Jahr: | 2022 |
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| Jahr: | July 7, 2022 |
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| Umfang: | 10 S. |
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| Fussnoten: | Gesehen am 08.08.2023 |
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| Titel Quelle: | Enthalten in: Journal of psychopharmacology |
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| Ort Quelle: | London [u.a.] : Sage, 1987 |
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| Jahr Quelle: | 2022 |
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| Band/Heft Quelle: | 36(2022), 10 vom: Okt., Seite 1136-1145 |
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| ISSN Quelle: | 1461-7285 |
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| 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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| DOI: | doi:10.1177/02698811221104063 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
kostenfrei: Volltext: https://doi.org/10.1177/02698811221104063 |
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| | kostenfrei: Volltext: https://journals.sagepub.com/doi/full/10.1177/02698811221104063 |
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| | DOI: https://doi.org/10.1177/02698811221104063 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1854618512 |
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| Verknüpfungen: | → Zeitschrift |
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Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients / Guiraud, Julien [VerfasserIn]; July 7, 2022 (Online-Ressource)
