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

Hepatitis C Clinical Trial

— Methaville  

Official title:

Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657397
• Other study ID #: ANRS Methaville
• 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

Related Conditions & MeSH terms

• Hepatitis C
• Methadone
• Substance Dependence
• Substance-Related Disorders

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