Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
Overview
- Phase
- Phase 3
- Intervention
- Methadone
- Conditions
- Hepatitis C
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- prevalence of non-users of street opioid after one year of treatment will be compared between arms.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 70 years patients needing methadone for their opioid dependence who are either naives of methadone treatment (prescribed) since at least 1 month
- •need to switch from buprenorphine to methadone treatment
- •negative test for pregnancy
Exclusion Criteria
- •co-dependent on alcohol and benzodiazepines,
- •pregnant women,
- •individual in irregular situation or who cannot be joined by phone.
Arms & Interventions
A
Methadone inducted by a primary care physician
Intervention: Methadone
B
Methadone inducted (in CSAPA)
Intervention: Methadone
Outcomes
Primary Outcomes
prevalence of non-users of street opioid after one year of treatment will be compared between arms.
Time Frame: one year
Secondary Outcomes
- Prevalence of non users of street opioids after three months of treatment(three months)
- Retention in treatment(one year)
- Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts(one year)
- cost-effectiveness(one year)
- surveillance of severe adverse events and overdose cases in each arm(Day -7 to Month 12)