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

NCT ID: NCT00657397

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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)

Conditions

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Hepatitis C Substance Dependence Methadone

Keywords

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Methadone Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Methadone inducted by a primary care physician

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

Methadone sirup once daily

B

Methadone inducted (in CSAPA)

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

Methadone sirup once daily

Interventions

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Methadone

Methadone sirup once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Morel, MD

Role: PRINCIPAL_INVESTIGATOR

CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France

Patrizia Carrieri, PHD

Role: STUDY_DIRECTOR

ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille

Locations

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CSST Le trait d'union

Boulogne, , France

Site Status

Countries

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France

References

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Perry D, Kirkwood JE, Doroshuk ML, Kelmer M, Korownyk CS, Ton J, Garrison SR. Opioid agonist therapy for opioid use disorder in primary versus specialty care. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD013672. doi: 10.1002/14651858.CD013672.pub2.

Reference Type DERIVED
PMID: 40919724 (View on PubMed)

Carrieri P, Vilotitch A, Nordmann S, Lions C, Michel L, Mora M, Morel A, Maradan G, Spire B, Roux P; Methaville Study Group. Decrease in self-reported offences and incarceration rates during methadone treatment: A comparison between patients switching from buprenorphine to methadone and maintenance treatment incident users (ANRS-Methaville trial). Int J Drug Policy. 2017 Jan;39:86-91. doi: 10.1016/j.drugpo.2016.08.005. Epub 2016 Oct 19.

Reference Type DERIVED
PMID: 27770695 (View on PubMed)

Roux P, Lions C, Vilotitch A, Michel L, Mora M, Maradan G, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Correlates of cocaine use during methadone treatment: implications for screening and clinical management (ANRS Methaville study). Harm Reduct J. 2016 Apr 5;13:12. doi: 10.1186/s12954-016-0100-7.

Reference Type DERIVED
PMID: 27048152 (View on PubMed)

Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P; Methaville Study Group. Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville). PLoS One. 2014 Nov 13;9(11):e112328. doi: 10.1371/journal.pone.0112328. eCollection 2014.

Reference Type DERIVED
PMID: 25393311 (View on PubMed)

Roux P, Lions C, Michel L, Mora M, Daulouede JP, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Factors associated with HCV risk practices in methadone-maintained patients: the importance of considering the couple in prevention interventions. Subst Abuse Treat Prev Policy. 2014 Sep 10;9:37. doi: 10.1186/1747-597X-9-37.

Reference Type DERIVED
PMID: 25209306 (View on PubMed)

Lions C, Carrieri MP, Michel L, Mora M, Marcellin F, Morel A, Spire B, Roux P; Methaville Study Group. Predictors of non-prescribed opioid use after one year of methadone treatment: an attributable-risk approach (ANRS-Methaville trial). Drug Alcohol Depend. 2014 Feb 1;135:1-8. doi: 10.1016/j.drugalcdep.2013.10.018. Epub 2013 Oct 31.

Reference Type DERIVED
PMID: 24268548 (View on PubMed)

Roux P, Michel L, Cohen J, Mora M, Morel A, Aubertin JF, Desenclos JC, Spire B, Carrieri PM; ANRS Methaville Study Group. Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial. BMC Public Health. 2012 Jun 28;12:488. doi: 10.1186/1471-2458-12-488.

Reference Type DERIVED
PMID: 22741944 (View on PubMed)

Other Identifiers

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ANRS Methaville

Identifier Type: -

Identifier Source: org_study_id