Abstract
ObjectiveMethadone 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.MethodsIn 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.ResultsIn 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).ConclusionsUnder 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.Trial registrationNumber Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511
Highlights
Methadone is included in the WHO list of essential medicines thanks to its effectiveness in treating opioid dependence, preventing HIV [1] and improving adherence to antiretroviral treatment in HIV-infected individuals [2]
While access to buprenorphine in primary care has been possible since 1996 thanks to its safety profile [3,4], methadone induction in France, as in most countries, is currently possible only in specialized centers caring for substance dependence
primary care (PC) physicians with patients potentially eligible for enrollment in the study were selected because if methadone induction in PC is officially adopted in France in the future, only PC physicians meeting the above criteria will be targeted by authorities as methadone prescribers
Summary
Methadone is included in the WHO list of essential medicines thanks to its effectiveness in treating opioid dependence, preventing HIV [1] and improving adherence to antiretroviral treatment in HIV-infected individuals [2]. Access to methadone remains limited because of the risk of overdose during induction, especially in countries where the need for methadone is even greater. While access to buprenorphine in primary care has been possible since 1996 thanks to its safety profile [3,4], methadone induction in France, as in most countries, is currently possible only in specialized centers caring for substance dependence (located in ad hoc sites or in hospitals) (hereafter specialized care or SC). The specific model of care for regulating methadone induction can greatly influence its safety as the risk of overdose during the induction phase remains a major concern. The regulations governing the extent to which methadone induction (i.e. until dosage stabilization) is authorized in primary care (PC) differ considerably. France, the United States and other countries have no such system currently in place
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