Hepatitis C Clinical Trial
— MethavilleOfficial title:
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.
Status | Completed |
Enrollment | 197 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CSST Le trait d'union | Boulogne |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalence of non-users of street opioid after one year of treatment will be compared between arms. | one year | No | |
Secondary | Prevalence of non users of street opioids after three months of treatment | three months | No | |
Secondary | Retention in treatment | one year | No | |
Secondary | Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts | one year | No | |
Secondary | cost-effectiveness | one year | No | |
Secondary | surveillance of severe adverse events and overdose cases in each arm | Day -7 to Month 12 | Yes |
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