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Completed

NCT Number: NCT00657397

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Methadone RNA Virus Infections Substance Dependence Substance-Related Disorders Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CSST Le trait d'union

Boulogne, 92100, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methadone

Drug

Methadone sirup once daily

Primary outcomes

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

    Time frame: one year

Secondary outcomes

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

    Time frame: three months

  2. Retention in treatment

    Time frame: one year

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

    Time frame: one year

  4. cost-effectiveness

    Time frame: one year

  5. surveillance of severe adverse events and overdose cases in each arm

    Time frame: Day -7 to Month 12

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Registry information

Official study title

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

Acronym: Methaville

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2008
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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