NCT00657397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

April 8, 2008

Last Update Submit

July 23, 2012

Conditions

Hepatitis CSubstance DependenceMethadone

Keywords

MethadoneSubstance Dependence

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (5)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Methadone inducted by a primary care physician

Drug: Methadone

B

ACTIVE COMPARATOR

Methadone inducted (in CSAPA)

Drug: Methadone

Interventions

MethadoneDRUG

Methadone sirup once daily

AB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • co-dependent on alcohol and benzodiazepines,
  • inmates,
  • pregnant women,
  • individual in irregular situation or who cannot be joined by phone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSST Le trait d'union

Boulogne, 92100, France

Location

Related Publications (7)

  • 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.

    PMID: 40919724DERIVED

  • 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.

    PMID: 27770695DERIVED

  • 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.

    PMID: 27048152DERIVED

  • 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.

    PMID: 25393311DERIVED

  • 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.

    PMID: 25209306DERIVED

  • 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.

    PMID: 24268548DERIVED

  • 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.

    PMID: 22741944DERIVED

MeSH Terms

Conditions

Hepatitis CSubstance-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Alain Morel, MD

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

    PRINCIPAL INVESTIGATOR

  • Patrizia Carrieri, PHD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

FR(1)