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 Becks 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
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
-
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.
-
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.
-
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.
-
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.
-
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.