Condition category
Mental and Behavioural Disorders
Date applied
22/10/2011
Date assigned
09/02/2012
Last edited
30/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People who are addicted to opiates such as heroin can be prescribed a heroin substitute such as methadone or buprenorphine to help them stop their drug use. The rapid increase in the use of opioid substitution treatment for drug users, mainly achieved through prescribing buprenorphine in primary care, has been successful in reducing HIV prevalence among drug users but is still inadequate for reducing the spread of hepatitis C. In France methadone treatment can currently only be started in drug centres but GPs can prescribe methadone after stabilisation of dosages. The main aim of this study is to compare patients who start methadone treatment in primary care and patients who start methadone treatment in Specialized Drug Addiction Treatment Centers, in order to find out whether the proportion of patients not using opioids after 1 year of treatment is the same. The other aims include assessing adherence to treatment, addictive behaviours, quality of life, psychiatric conditions, reduction in criminal acts, and cost effectiveness.

Who can participate?
Patients aged between 18 and 70 who need methadone treatment for their opioid dependence, and who have either never received methadone, have not had any methadone for at least 1 month, or need to switch from buprenorphine to methadone

What does the study involve?
Participants are randomly allocated to start taking methadone either in primary care or a specialised centre for opioid dependence. After stabilisation of dosages the participants can choose whether to change groups. The study lasts for 12 months with examinations and interviews at the start of the study and after 3, 6 and 12 months. The prevalence of daily opioid use after one year of treatment is compared between groups. The prevalence of other addictive behaviors, adherence to treatment, improvement in quality of life, psychiatric conditions, reduction in criminal acts and cost-effectiveness are also assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
ANRS - French Aids Research Agency (France)

When is the study starting and how long is it expected to run for?
January 2009 to January 2012

Who is funding the study?
1. ANRS - French Aids Research Agency (France)
2. French Ministry of Health
 (France)

Who is the main contact?
Dr Patrizia Carrieri
pmcarrieri@aol.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrizia Carrieri

ORCID ID

Contact details

23 rue Stanislas Torrents
Marseille
13006
France
+33 (0)4 96 10 28 75
pmcarrieri@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00657397

Protocol/serial number

2008-001338-28

Study information

Scientific title

Induction of methadone in primary care (ANRS-METHAVILLE): a phase III randomized non-inferiority trial in France

Acronym

Study hypothesis

The main hypothesis is that the delivery model used for first prescription (primo-prescription) of methadone does not influence injection relapses nor treatment´s effectiveness. More specifically, we hypothesize a non-inferiority after one year treatment in patients who were inducted in primary compared to those who initiated methadone in specialized centers in terms of prevalence of daily opioid users.

Ethics approval

Commissions for the Protection of Person (Comités de Protection des Personne) (CPP.IDF.VI), 29/05/2008, ref: 08-015

Study design

Randomised multicentre non-inferiority control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Opioid dependence

Intervention

Intervention group: 14 day induction of methadone treatment in primary care by a trained General Practitionner.
Control group: 14 day induction of methadone treatment in Specialized Drug Addiction Treatment Centers

After the 14 induction days, the participant could choose to remain to the allocated setting or to change to the other one (primary care or specialized center).

Intervention type

Drug

Phase

Phase III

Drug names

Methadone

Primary outcome measures

1. Daily opioid use
2. Method of measurement: Opiate Treatment Index (OTI) - a multi-dimensional questionnaire based in patients’ self-report (REF OTI- Darke et al, 1992) 12 months after enrolment (visit M12)
3. Prevalence (%) of opioid users at M12

Secondary outcome measures

1. The prevalence of other hepatitis C virus (HCV) risk transmission practices is being documented using a series of questions extracted from a standardized questionnaire specific for this purpose, the BBV-TRAQ (Fry and Lintzeris, 2003; Tucker et al, 2004) at M12
2. Other indicators relevant for the purpose of this thesis are being collected:
2.1. Depressive symptoms Beck’s H questionnaire (Beck et al, 1985)
2.2. Alcohol consumption with the AUDIT questionnaire (Saunders et al, 1993)
2.3. Patient-health care provider relationship (Smith et al, 2006)
2.4. Adherence to methadone
2.5. Urinary drug screening and socio-demographic information on history of incarceration and contact with associations

Overall trial start date

02/01/2009

Overall trial end date

02/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Between 18 and 70 years old
2. Opioid dependent and with an indication for methadone treatment
3. Being naive or without any previous methadone treatment during the last 30 days or having failed with buprenorphine treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

197

Participant exclusion criteria

1. Contraindication to methadone treatment
2. Co-dependence on alcohol and benzodiazepines
3. Inmates
4. Pregnant women
5. Individual in irregular situation or who cannot be joined by phone

Recruitment start date

02/01/2009

Recruitment end date

02/01/2012

Locations

Countries of recruitment

France

Trial participating centre

23 rue Stanislas Torrents
Marseille
13006
France

Sponsor information

Organisation

ANRS - French Aids Research Agency [Agence Nationale de Recherche sur le Sida] (France)

Sponsor details

c/o Ms Isabelle Porteret
101 rue de Tolbiac
Paris
75013
France
+33 1 53 94 60 09
Isabelle.porteret@anrs.fr

Sponsor type

Research organisation

Website

http://www.anrs.fr/

Funders

Funder type

Research organisation

Funder name

ANRS (French Aids Research Agency) (France)

Alternative name(s)

National Agency for AIDS Research, National Agency for Research on AIDS and Viral Hepatitis, National Agency of Research on AIDS and Viral Hepatitis, ANRS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

France

Funder name

Ministry of Health
 (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22741944
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24268548
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25209306
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25393311
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27048152

Publication citations

  1. Protocol

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

  2. Results

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

  3. Results

    Roux P, Lions C, Michel L, Mora M, Daulouède JP, Marcellin F, Spire B, Morel A, Carrieri PM, 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, 9, 1, 37, doi: 10.1186/1747-597X-9-37.

  4. Results

    Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P, , Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)., PLoS ONE, 2014, 9, 11, e112328, doi: 10.1371/journal.pone.0112328.

  5. Results

    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 , 13, 1, 12, doi: 10.1186/s12954-016-0100-7.

Additional files

Editorial Notes

30/03/2017: Plain English summary added. 08/04/2016: Publication reference added.