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

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis (Other)

Overall Status

Completed

CT.gov ID

NCT00657397

Collaborator

(none)

197

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Substance Dependence Methadone	Drug: Methadone	Phase 3

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

197 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Methadone inducted by a primary care physician	Drug: Methadone Methadone sirup once daily
Active Comparator: B Methadone inducted (in CSAPA)	Drug: Methadone Methadone sirup once daily

Arm

Intervention/Treatment

Experimental: A

Methadone inducted by a primary care physician

Drug: Methadone

Methadone sirup once daily

Active Comparator: B

Methadone inducted (in CSAPA)

Drug: Methadone

Methadone sirup once daily

Outcome Measures

Primary Outcome Measures

prevalence of non-users of street opioid after one year of treatment will be compared between arms. [one year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CSST Le trait d'union	Boulogne		France	92100

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator: Alain Morel, MD, CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France
Study Director: Patrizia Carrieri, PHD, ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille