ISRCTN ISRCTN31125511
DOI https://doi.org/10.1186/ISRCTN31125511
ClinicalTrials.gov number NCT00657397
Secondary identifying numbers 2008-001338-28
Submission date
22/10/2011
Registration date
09/02/2012
Last edited
30/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Patrizia Carrieri
Scientific

23 rue Stanislas Torrents
Marseille
13006
France

Phone +33 (0)4 96 10 28 75
Email pmcarrieri@aol.com

Study information

Study designRandomised multicentre non-inferiority control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleInduction of methadone in primary care (ANRS-METHAVILLE): a phase III randomized non-inferiority trial in France
Study objectivesThe 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(s)Commissions for the Protection of Person (Comités de Protection des Personne) (CPP.IDF.VI), 29/05/2008, ref: 08-015
Health condition(s) or problem(s) studiedOpioid dependence
InterventionIntervention 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Methadone
Primary outcome measure1. 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 measures1. 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 study start date02/01/2009
Completion date02/01/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants197
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment02/01/2009
Date of final enrolment02/01/2012

Locations

Countries of recruitment

  • France

Study participating centre

23 rue Stanislas Torrents
Marseille
13006
France

Sponsor information

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

c/o Ms Isabelle Porteret
101 rue de Tolbiac
Paris
75013
France

Phone +33 1 53 94 60 09
Email Isabelle.porteret@anrs.fr
Website http://www.anrs.fr/
ROR logo "ROR" https://ror.org/01kv58h76

Funders

Funder type

Research organisation

ANRS (French Aids Research Agency) (France)
Private sector organisation / Other non-profit organizations
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
Location
France
Ministry of Health
 (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 28/06/2012 Yes No
Results article results 01/02/2014 Yes No
Results article results 10/09/2014 Yes No
Results article results 13/11/2014 Yes No
Results article results 05/04/2016 Yes No

Editorial Notes

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