Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)
Identifieur interne : 000041 ( Pmc/Checkpoint ); précédent : 000040; suivant : 000042Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)
Auteurs : Patrizia Maria Carrieri [France] ; Laurent Michel [France] ; Caroline Lions [France] ; Julien Cohen [France] ; Muriel Vray [France] ; Marion Mora [France] ; Fabienne Marcellin [France] ; Bruno Spire [France] ; Alain Morel [France] ; Perrine Roux [France]Source :
- PLoS ONE [ 1932-6203 ] ; 2014.
Abstract
Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.
In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.
In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).
Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.
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DOI: 10.1371/journal.pone.0112328
PubMed: 25393311
PubMed Central: 4231094
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type="doi">10.1371/journal.pone.0112328</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000012</idno><idno type="wicri:Area/Pmc/Curation">000012</idno><idno type="wicri:Area/Pmc/Checkpoint">000041</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)</title><author><name sortKey="Carrieri, Patrizia Maria" sort="Carrieri, Patrizia Maria" uniqKey="Carrieri P" first="Patrizia Maria" last="Carrieri">Patrizia Maria Carrieri</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Michel, Laurent" sort="Michel, Laurent" uniqKey="Michel L" first="Laurent" last="Michel">Laurent Michel</name><affiliation wicri:level="1"><nlm:aff id="aff4"><addr-line>INSERM, Research Unit 669, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Research Unit 669, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff5"><addr-line>Univ Paris-Sud and Univ Paris Descartes, UMR-S0669, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Univ Paris-Sud and Univ Paris Descartes, UMR-S0669, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Centre Pierre Nicole, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Pierre Nicole, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Lions, Caroline" sort="Lions, Caroline" uniqKey="Lions C" first="Caroline" last="Lions">Caroline Lions</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Cohen, Julien" sort="Cohen, Julien" uniqKey="Cohen J" first="Julien" last="Cohen">Julien Cohen</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Vray, Muriel" sort="Vray, Muriel" uniqKey="Vray M" first="Muriel" last="Vray">Muriel Vray</name><affiliation wicri:level="1"><nlm:aff id="aff7"><addr-line>Unité de Recherche et d'Expertise en Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Unité de Recherche et d'Expertise en Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff8"><addr-line>Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut National de la Santé et de la Recherche Médicale (INSERM), Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mora, Marion" sort="Mora, Marion" uniqKey="Mora M" first="Marion" last="Mora">Marion Mora</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Marcellin, Fabienne" sort="Marcellin, Fabienne" uniqKey="Marcellin F" first="Fabienne" last="Marcellin">Fabienne Marcellin</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Spire, Bruno" sort="Spire, Bruno" uniqKey="Spire B" first="Bruno" last="Spire">Bruno Spire</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Morel, Alain" sort="Morel, Alain" uniqKey="Morel A" first="Alain" last="Morel">Alain Morel</name><affiliation wicri:level="1"><nlm:aff id="aff9"><addr-line>Oppelia, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Oppelia, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Roux, Perrine" sort="Roux, Perrine" uniqKey="Roux P" first="Perrine" last="Roux">Perrine Roux</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR912 (SESSTIM), Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Aix Marseille Université, UMR_S912, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName><orgName type="university">Université d'Aix-Marseille</orgName><placeName><settlement type="city">Marseille</settlement><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective</title><p>Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.</p></sec><sec><title>Methods</title><p>In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.</p></sec><sec><title>Results</title><p>In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).</p></sec><sec><title>Conclusions</title><p>Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.</p></sec><sec><title>Trial registration</title><p>Number Eudract <ext-link ext-link-type="uri" xlink:href="https://eudract.ema.europa.eu/">2008-001338-28</ext-link>; ClinicalTrials.gov: <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/">NCT00657397</ext-link>; International Standard Randomized Controlled Trial Number Register <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/isrctn/">ISRCTN31125511</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Macarthur, Gj" uniqKey="Macarthur G">GJ Macarthur</name></author><author><name sortKey="Minozzi, S" uniqKey="Minozzi S">S Minozzi</name></author><author><name sortKey="Martin, N" uniqKey="Martin N">N Martin</name></author><author><name sortKey="Vickerman, P" uniqKey="Vickerman 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25393311</article-id><article-id pub-id-type="pmc">4231094</article-id><article-id pub-id-type="publisher-id">PONE-D-14-09969</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0112328</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline-v2"><subject>Medicine and Health Sciences</subject><subj-group><subject>Epidemiology</subject></subj-group><subj-group><subject>Infectious Diseases</subject></subj-group><subj-group><subject>Mental Health and Psychiatry</subject></subj-group></subj-group></article-categories><title-group><article-title>Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)</article-title><alt-title alt-title-type="running-head">Methadone Induction in Primary Care</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Carrieri</surname><given-names>Patrizia Maria</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Michel</surname><given-names>Laurent</given-names></name><xref ref-type="aff" rid="aff4"><sup>4</sup></xref><xref ref-type="aff" rid="aff5"><sup>5</sup></xref><xref ref-type="aff" rid="aff6"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lions</surname><given-names>Caroline</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Cohen</surname><given-names>Julien</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Vray</surname><given-names>Muriel</given-names></name><xref ref-type="aff" rid="aff7"><sup>7</sup></xref><xref ref-type="aff" rid="aff8"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Mora</surname><given-names>Marion</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Marcellin</surname><given-names>Fabienne</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Spire</surname><given-names>Bruno</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Morel</surname><given-names>Alain</given-names></name><xref ref-type="aff" rid="aff9"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Roux</surname><given-names>Perrine</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><collab>the Methaville Study Group</collab><xref ref-type="author-notes" rid="fn1"><sup>¶</sup></xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>INSERM UMR912 (SESSTIM), Marseille, France</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Aix Marseille Université, UMR_S912, Marseille, France</addr-line></aff><aff id="aff3"><label>3</label><addr-line>ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France</addr-line></aff><aff id="aff4"><label>4</label><addr-line>INSERM, Research Unit 669, Paris, France</addr-line></aff><aff id="aff5"><label>5</label><addr-line>Univ Paris-Sud and Univ Paris Descartes, UMR-S0669, Paris, France</addr-line></aff><aff id="aff6"><label>6</label><addr-line>Centre Pierre Nicole, Paris, France</addr-line></aff><aff id="aff7"><label>7</label><addr-line>Unité de Recherche et d'Expertise en Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France</addr-line></aff><aff id="aff8"><label>8</label><addr-line>Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France</addr-line></aff><aff id="aff9"><label>9</label><addr-line>Oppelia, Paris, France</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Mendelson</surname><given-names>John E.</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>California Pacific Medical Center Research Institute, United States of America</addr-line></aff><author-notes><corresp id="cor1">* E-mail: <email>pmcarrieri@aol.com</email></corresp><fn fn-type="conflict"><p><bold>Competing Interests: </bold>The authors have declared that no competing interests exist.</p></fn><fn fn-type="con"><p>Conceived and designed the experiments: PMC AM PR LM MV BS. Performed the experiments: AM PMC PR LM MM. Analyzed the data: JC CL FM PMC. Contributed reagents/materials/analysis tools: MM AM LM PR PMC. Wrote the manuscript: PMC. Contributed to the writing of the manuscript: PR.</p></fn><fn id="fn1" fn-type="other"><p>¶ Membership of the Methaville Study Group is provided in the Acknowledgments.</p></fn></author-notes><pub-date pub-type="collection"><year>2014</year></pub-date><pub-date pub-type="epub"><day>13</day><month>11</month><year>2014</year></pub-date><volume>9</volume><issue>11</issue><elocation-id>e112328</elocation-id><history><date date-type="received"><day>6</day><month>3</month><year>2014</year></date><date date-type="accepted"><day>29</day><month>9</month><year>2014</year></date></history><permissions><copyright-year>2014</copyright-year><copyright-holder>Carrieri et al</copyright-holder><license><license-p>This is an open-access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License</ext-link>, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p></license></permissions><abstract><sec><title>Objective</title><p>Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.</p></sec><sec><title>Methods</title><p>In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.</p></sec><sec><title>Results</title><p>In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).</p></sec><sec><title>Conclusions</title><p>Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.</p></sec><sec><title>Trial registration</title><p>Number Eudract <ext-link ext-link-type="uri" xlink:href="https://eudract.ema.europa.eu/">2008-001338-28</ext-link>; ClinicalTrials.gov: <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/">NCT00657397</ext-link>; International Standard Randomized Controlled Trial Number Register <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/isrctn/">ISRCTN31125511</ext-link></p></sec></abstract><funding-group><funding-statement>The study received external funding by the French National Agency for Research on Aids and Viral Hepatitis (ANRS) and the French Ministry of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</funding-statement></funding-group><counts><page-count count="10"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>The authors confirm that, for approved reasons, there are some access restrictions on the data. Data collection and management are performed by the center of methodology and management of ORS PACA-INSERM-IRD UMR912, and cannot be made publicly available for ethical and legal reasons. The data is available upon request and written requests may be sent to the corresponding author.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>The authors confirm that, for approved reasons, there are some access restrictions on the data. Data collection and management are performed by the center of methodology and management of ORS PACA-INSERM-IRD UMR912, and cannot be made publicly available for ethical and legal reasons. The data is available upon request and written requests may be sent to the corresponding author.</p></notes></front></pmc><affiliations><list><country><li>France</li></country><region><li>Provence-Alpes-Côte d'Azur</li></region><settlement><li>Marseille</li><li>Paris</li></settlement><orgName><li>Université d'Aix-Marseille</li></orgName></list><tree><country name="France"><noRegion><name sortKey="Carrieri, Patrizia Maria" sort="Carrieri, Patrizia Maria" uniqKey="Carrieri P" first="Patrizia Maria" last="Carrieri">Patrizia Maria Carrieri</name></noRegion><name sortKey="Carrieri, Patrizia Maria" sort="Carrieri, Patrizia Maria" uniqKey="Carrieri P" first="Patrizia Maria" last="Carrieri">Patrizia Maria Carrieri</name><name sortKey="Carrieri, Patrizia Maria" sort="Carrieri, Patrizia Maria" uniqKey="Carrieri P" first="Patrizia Maria" last="Carrieri">Patrizia Maria Carrieri</name><name sortKey="Cohen, Julien" sort="Cohen, Julien" uniqKey="Cohen J" first="Julien" last="Cohen">Julien Cohen</name><name sortKey="Cohen, Julien" sort="Cohen, Julien" uniqKey="Cohen J" first="Julien" last="Cohen">Julien Cohen</name><name sortKey="Cohen, Julien" sort="Cohen, Julien" uniqKey="Cohen J" first="Julien" last="Cohen">Julien Cohen</name><name sortKey="Lions, Caroline" sort="Lions, Caroline" uniqKey="Lions C" first="Caroline" last="Lions">Caroline Lions</name><name sortKey="Lions, Caroline" sort="Lions, Caroline" uniqKey="Lions C" first="Caroline" last="Lions">Caroline Lions</name><name sortKey="Lions, Caroline" sort="Lions, Caroline" uniqKey="Lions C" first="Caroline" last="Lions">Caroline Lions</name><name sortKey="Marcellin, Fabienne" sort="Marcellin, Fabienne" uniqKey="Marcellin F" first="Fabienne" last="Marcellin">Fabienne Marcellin</name><name sortKey="Marcellin, Fabienne" sort="Marcellin, Fabienne" uniqKey="Marcellin F" first="Fabienne" last="Marcellin">Fabienne Marcellin</name><name sortKey="Marcellin, Fabienne" sort="Marcellin, Fabienne" uniqKey="Marcellin F" first="Fabienne" last="Marcellin">Fabienne Marcellin</name><name sortKey="Michel, Laurent" sort="Michel, Laurent" uniqKey="Michel L" first="Laurent" last="Michel">Laurent Michel</name><name sortKey="Michel, Laurent" sort="Michel, Laurent" uniqKey="Michel L" first="Laurent" last="Michel">Laurent Michel</name><name sortKey="Michel, Laurent" sort="Michel, Laurent" uniqKey="Michel L" first="Laurent" last="Michel">Laurent Michel</name><name sortKey="Mora, Marion" sort="Mora, Marion" uniqKey="Mora M" first="Marion" last="Mora">Marion Mora</name><name sortKey="Mora, Marion" sort="Mora, Marion" uniqKey="Mora M" first="Marion" last="Mora">Marion Mora</name><name sortKey="Mora, Marion" sort="Mora, Marion" uniqKey="Mora M" first="Marion" last="Mora">Marion Mora</name><name sortKey="Morel, Alain" sort="Morel, Alain" uniqKey="Morel A" first="Alain" last="Morel">Alain Morel</name><name sortKey="Roux, Perrine" sort="Roux, Perrine" uniqKey="Roux P" first="Perrine" last="Roux">Perrine Roux</name><name sortKey="Roux, Perrine" sort="Roux, Perrine" uniqKey="Roux P" first="Perrine" last="Roux">Perrine Roux</name><name sortKey="Roux, Perrine" sort="Roux, Perrine" uniqKey="Roux P" first="Perrine" last="Roux">Perrine Roux</name><name sortKey="Spire, Bruno" sort="Spire, Bruno" uniqKey="Spire B" first="Bruno" last="Spire">Bruno Spire</name><name sortKey="Spire, Bruno" sort="Spire, Bruno" uniqKey="Spire B" first="Bruno" last="Spire">Bruno Spire</name><name sortKey="Spire, Bruno" sort="Spire, Bruno" uniqKey="Spire B" first="Bruno" last="Spire">Bruno Spire</name><name sortKey="Vray, Muriel" sort="Vray, Muriel" uniqKey="Vray M" first="Muriel" last="Vray">Muriel Vray</name><name sortKey="Vray, Muriel" sort="Vray, Muriel" uniqKey="Vray M" first="Muriel" last="Vray">Muriel Vray</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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