Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices

Condition(s) targeted: Hepatitis C; Substance Dependence; Methadone

Intervention: Methadone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis

Official(s) and/or principal investigator(s):
Alain Morel, MD, Principal Investigator, Affiliation: CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France
Patrizia Carrieri, PHD, Study Director, Affiliation: ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille

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.

Official title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: prevalence of non-users of street opioid after one year of treatment will be compared between arms.

Secondary outcome:

Prevalence of non users of street opioids after three months of treatment

Retention in treatment

Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts

cost-effectiveness

surveillance of severe adverse events and overdose cases in each arm

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)

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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,

- inmates,

- pregnant women,

- individual in irregular situation or who cannot be joined by phone.

CSST Le trait d'union, Boulogne 92100, France

Starting date: January 2009
Last updated: July 23, 2012