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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00657397
Other study ID # ANRS Methaville
Secondary ID
Status Completed
Phase Phase 3
First received April 8, 2008
Last updated July 23, 2012
Start date January 2009
Est. completion date December 2011

Study information

Verified date July 2012
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Methadone
Methadone sirup once daily

Locations

Country Name City State
France CSST Le trait d'union Boulogne

Sponsors (1)

Lead Sponsor Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

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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