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

July 23, 2012 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne, France, 92100
        • CSST Le trait d'union

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of non-users of street opioid after one year of treatment will be compared between arms.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of non users of street opioids after three months of treatment
Time Frame: three months
three months
Retention in treatment
Time Frame: one year
one year
Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts
Time Frame: one year
one year
cost-effectiveness
Time Frame: one year
one year
surveillance of severe adverse events and overdose cases in each arm
Time Frame: Day -7 to Month 12
Day -7 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS Methaville

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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