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

Phase 3

Completed

• Conditions: Hepatitis C; Substance Dependence; Methadone
• Interventions: Drug: Methadone

• Registration Number: NCT00657397
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Methadone	Methadone inducted by a primary care physician
B	Methadone	Methadone inducted (in CSAPA)

Primary Outcome Measures

Name	Time	Method
prevalence of non-users of street opioid after one year of treatment will be compared between arms.	one year

Secondary Outcome Measures

Name	Time	Method
Prevalence of non users of street opioids after three months of treatment	three months
Retention in treatment	one year
Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts	one year
cost-effectiveness	one year
surveillance of severe adverse events and overdose cases in each arm	Day -7 to Month 12

Trial Locations

Locations (1)

CSST Le trait d'union; 🇫🇷 Boulogne, France