Hepatitis C Clinical Trial
Official title:
Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved
through the possibility of prescribing buprenorphine in primary care has been successful in
reducing HIV prevalence among drug users but still inadequate for reducing the spread of
HCV. To date, methadone in France can only be initialised in drug centres but GPs can
prescribe methadone after stabilisation of dosages.
This study was born as an answer to a request from the French Minister of Health that
supports the initialisation of methadone in primary care in order to improve coverage by OST
(now 70%) in drug users.
We aimed to test the non inferiority of the proportion of non users of street-opioids after
one year of treatment in patients inducted in primary care (PC) vs.those inducted in a
specialised center for substance dependence (CSAPA).
In this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent
individuals were randomized to start methadone either in PC or in a CSAPA. After
stabilization of methadone dosage (~2 weeks), patients could change arm. Follow-up
assessments through medical questionnaires and phone interviews was scheduled at month 0
(M0, enrolment) M3, M6, M12. The opiate treatment index (OTI) was used for computing the
proportion of patients reporting no use of street opioids in the last month at M12 (primary
outcome) in those inducted in PC or in a CSAPA and the non inferiority margins.
Primary analysis was by intention to treat (ITT)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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