Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)
Identifieur interne : 000440 ( Ncbi/Curation ); précédent : 000439; suivant : 000441Methadone 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.
Descripteurs français
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Methadone.
- geographic : France.
- drug therapy : Opioid-Related Disorders.
- Adult, Female, Humans, Induction Chemotherapy, Male, Primary Health Care.
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.
Number Eudract
Url:
DOI: 10.1371/journal.pone.0112328
PubMed: 25393311
PubMed Central: 4231094
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PMC:4231094Le document en format XML
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<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>
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</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>
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</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>
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</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><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Female</term>
<term>France</term>
<term>Humans</term>
<term>Induction Chemotherapy</term>
<term>Male</term>
<term>Methadone (therapeutic use)</term>
<term>Opioid-Related Disorders (drug therapy)</term>
<term>Primary Health Care</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Methadone</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Opioid-Related Disorders</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Female</term>
<term>Humans</term>
<term>Induction Chemotherapy</term>
<term>Male</term>
<term>Primary Health Care</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term>
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<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>
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