Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).
OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Patrizia Maria
PM
Carrieri
INSERM, Research Unit 669, Paris, France; Univ Paris-Sud and Univ Paris Descartes, UMR-S0669, Paris, France; Centre Pierre Nicole, Paris, France.
Laurent
L
Michel
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Caroline
C
Lions
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Julien
J
Cohen
Unité de Recherche et d'Expertise en Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France; Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Muriel
M
Vray
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Marion
M
Mora
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Fabienne
F
Marcellin
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Bruno
B
Spire
Oppelia, Paris, France.
Alain
A
Morel
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
Perrine
P
Roux
D000328:Adult; D005260:Female; D005602:France; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D011320:Primary Health Care
D008691:Methadone