{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T10:13:55Z","timestamp":1784628835142,"version":"3.55.0"},"reference-count":48,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T00:00:00Z","timestamp":1657152000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T00:00:00Z","timestamp":1657152000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Laboratorio Farmaceutico CT"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>To confirm the SMO effect on (sustained) MoA in detoxified alcohol-dependent patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>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\u2009months SMO (3.3\u20133.9\u2009g\/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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      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\u2009days, 95% confidence interval (17.6\u201368.5;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.001). Since significant heterogeneity of effect across sites and unequal sample sizes among sites (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20093\u201366) were identified, a site-level random meta-analysis was performed with results supporting the pre-specified analysis: mean difference +32.4\u2009days,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.014. The SMO effect was sustained during the medication-free follow-up period. SMO was well-tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Results of this large RCT in alcohol-dependent patients demonstrated a significant and clinically relevant sustained effect of SMO on CAD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov Identifier: NCT04648423<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811221104063","type":"journal-article","created":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T08:10:38Z","timestamp":1657181438000},"page":"1136-1145","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":15,"title":["Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial"],"prefix":"10.1177","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1284-7949","authenticated-orcid":false,"given":"Julien","family":"Guiraud","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands"},{"name":"D&amp;A Pharma, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Addolorato","sequence":"additional","affiliation":[{"name":"Alcohol Use Disorder and Alcohol Related Disease Unit, Department of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy"},{"name":"Internal Medicine Unit, Columbus-Gemelli Hospital, Department of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariangela","family":"Antonelli","sequence":"additional","affiliation":[{"name":"Internal Medicine Unit, Columbus-Gemelli Hospital, Department of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henri-Jean","family":"Aubin","sequence":"additional","affiliation":[{"name":"French Institute of Health and Medical Research (Inserm), Centre de Recherche en Epid\u00e9miologie et Sant\u00e9 des Populations (CESP), Universite Paris-Saclay, Villejuif, France"},{"name":"Addiction Research and Treatment Center, Paul Brousse Hospital, Paris-Sud University, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"de Bejczy","sequence":"additional","affiliation":[{"name":"Section of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amine","family":"Benyamina","sequence":"additional","affiliation":[{"name":"Addiction Research and Treatment Center, Paul Brousse Hospital, Paris-Sud University, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Cacciaglia","sequence":"additional","affiliation":[{"name":"Laboratorio Farmaceutico CT, San Remo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8953-8338","authenticated-orcid":false,"given":"Fabio","family":"Caputo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, SS. Annunziata Hospital, Cento (Ferrara), University of Ferrara, Italy"},{"name":"Centre for the Study and Treatment of Alcohol-Related Diseases, Department of Translational Medicine, University of Ferrara, Ferrara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurice","family":"Dematteis","sequence":"additional","affiliation":[{"name":"Department of Addiction Medicine, Grenoble-Alpes University Hospital, and Faculty of Medicine, Grenoble Alpes University, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8518-5547","authenticated-orcid":false,"given":"Anna","family":"Ferrulli","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Milan, Italy"},{"name":"Department of Biomedical Sciences for Health, University of Milan, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna E","family":"Goudriaan","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands"},{"name":"Arkin, Department of Research and Quality of Care, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoni","family":"Gual","sequence":"additional","affiliation":[{"name":"Psychiatry Department, Neurosciences Institute, Hospital Clinic, IDIBAPS, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Otto-Michael","family":"Lesch","sequence":"additional","affiliation":[{"name":"University Clinic of Psychiatry and Psychotherapy, Department of Social Psychiatry, Medical University of Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Icro","family":"Maremmani","sequence":"additional","affiliation":[{"name":"Santa Chiara University Hospital, University of Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3932-3803","authenticated-orcid":false,"given":"Antonio","family":"Mirijello","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza General Hospital, San Giovanni Rotondo (FG), Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J","family":"Nutt","sequence":"additional","affiliation":[{"name":"Centre for Neuropsychopharmacology, Imperial College London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Paille","sequence":"additional","affiliation":[{"name":"Department of Addiction Treatment, University Hospital, Vandoeuvre-l\u00e8s-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Perney","sequence":"additional","affiliation":[{"name":"Addiction Medicine, CHU N\u00eemes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roch","family":"Poulnais","sequence":"additional","affiliation":[{"name":"D&amp;A Pharma, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quentin","family":"Raffaillac","sequence":"additional","affiliation":[{"name":"D&amp;A Pharma, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Rehm","sequence":"additional","affiliation":[{"name":"Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada"},{"name":"Clinical Psychology &amp; Psychotherapy Technical University Dresden, Dresden, Germany"},{"name":"Department of International Health Projects, Institute for Leadership and Health Management, I.M. 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