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

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ClinicalTrials.gov Identifier: NCT00657397
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : July 24, 2012
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 )

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 Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. prevalence of non-users of street opioid after one year of treatment will be compared between arms. [ Time Frame: one year ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00657397     History of Changes
Other Study ID Numbers: ANRS Methaville
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by 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 ):
Methadone
Substance Dependence

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