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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT00657397
First received: April 8, 2008
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Hepatitis C
Substance Dependence
Methadone
Drug: Methadone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • prevalence of non-users of street opioid after one year of treatment will be compared between arms. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of non users of street opioids after three months of treatment [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Retention in treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts [ Time Frame: one year ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
  • surveillance of severe adverse events and overdose cases in each arm [ Time Frame: Day -7 to Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 197
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657397

Locations
France
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
  More Information

No publications provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT00657397     History of Changes
Other Study ID Numbers: ANRS Methaville
Study First Received: April 8, 2008
Last Updated: July 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Methadone
Substance Dependence

Additional relevant MeSH terms:
Hepatitis C
Substance-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
RNA Virus Infections
Virus Diseases
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014