Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices (Methaville)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00657397|
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : July 24, 2012
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Methadone inducted by a primary care physician
Methadone sirup once daily
Active Comparator: B
Methadone inducted (in CSAPA)
Methadone sirup once daily
- prevalence of non-users of street opioid after one year of treatment will be compared between arms. [ Time Frame: one year ]
- Prevalence of non users of street opioids after three months of treatment [ Time Frame: three months ]
- Retention in treatment [ Time Frame: 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 ]
- cost-effectiveness [ Time Frame: one year ]
- surveillance of severe adverse events and overdose cases in each arm [ Time Frame: Day -7 to Month 12 ]
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
|CSST Le trait d'union|
|Boulogne, France, 92100|
|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|