Methadone induction in primary care
| 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
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
Scientific
23 rue Stanislas Torrents
Marseille
13006
France
| Phone | +33 (0)4 96 10 28 75 |
|---|---|
| pmcarrieri@aol.com |
Study information
| Study design | Randomised multicentre non-inferiority control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Induction of methadone in primary care (ANRS-METHAVILLE): a phase III randomized non-inferiority trial in France |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Methadone |
| Primary outcome measure | 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 study start date | 02/01/2009 |
| Completion date | 02/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 197 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/01/2009 |
| Date of final enrolment | 02/01/2012 |
Locations
Countries of recruitment
- France
Study participating centre
13006
France
Sponsor information
Research organisation
c/o Ms Isabelle Porteret
101 rue de Tolbiac
Paris
75013
France
| Phone | +33 1 53 94 60 09 |
|---|---|
| Isabelle.porteret@anrs.fr | |
| Website | http://www.anrs.fr/ |
"ROR" |
https://ror.org/01kv58h76 |
Funders
Funder type
Research organisation
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
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
