ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 73307
| General | |
| Identification | |
| Detailed name | Cohort of Opioid-Dependent Subjects Starting Methadone Treatment |
| Sign or acronym | Méthaville ANRS (Agency for Research on AIDS and Viral Hepatitis) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ANSM 2008- A0277-48. Eudract number 2008-001338-28, ClinicalTrials.gov identifier: NCT00657397 and International Standard Randomised Controlled Trial Number Register ISRCTN31125511. |
| General Aspects | |
| Medical area |
General practice |
| Pathology (details) | Opioid addiction |
| Health determinants |
Addictions Medicine |
| Keywords | methadone, opioids, buprenorphine, cannabis and other illicit substances, treatment, addiction |
| Scientific investigator(s) (Contact) | |
| Name of the director | Carrieri |
| Surname | Patrizia |
| pmcarrieri@aol.com | |
| Unit | Communicable diseases; healthcare systems; companies (ESSEM) |
| Organization | SESSTIM |
| Name of the director | Morel |
| Surname | Alain |
| Address | Oppelia |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | ANRS, Ministry of Health |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM ANRS |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. | 221 opioid/opiate users wishing to enter a methadone programme were randomly divided into two groups: 155 began methadone treatment with a private general practitioner and 66 were treated in a specialised centre. |
| Database objective | |
| Main objective | To compare the non-inferiority of daily opioid use after one year of treatment (trial phase) in opiate-dependent patients that began methadone treatment through two different arms: private care versus specialised centres for substance dependence (CSAPA). After stabilising the prescribed methadone dose, patients may select the treatment location from the centres and investigators included in the study (2 initial arms may result in 4 possible groups). Secondary aims involve comparing the prevalence of HCV risk behaviours and treatment effectiveness among the groups during a 3-year follow-up in terms of: treatment adherence; prevalence of addictive behaviours; improvement in social insertion and quality of life; prevalence of psychiatric comorbidities; reduction in criminal acts; treatment satisfaction and cost effectiveness. |
| Inclusion criteria | Opioid/opiate users wishing to enter a methadone programme. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 221 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Health episodes; withdrawal symptoms; depressive episodes and suicide risk; pain |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Details of collected declarative data | Sex; age; cannabis and drug use; history of drug use. Social factors: secondary school graduation certificate; children; living with partner; employment; housing; requiring food aid and history of incarceration. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception Others |
| Care consumption (detail) |
Medicines consumption |
| Quality of life/perceived health (detail) | SF12, symptoms experienced. |
| Other (detail) | Psychoactive substance use; alcohol; criminal acts; doctor-patient relationship; psychiatric comorbidities and infections |
| Procedures | |
| Data collection method | By participating physicians (private and CSAPA) |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by contact with the referring doctor |
| Details on monitoring of participants | 1-month follow-up with visits at 3, 6 and 12 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Methadone+Maintenance+Treatment+AND+opioid-dependent+AND++Carrieri+MP+[Author]%29+OR+M%C3%A9thaville |
| Link to the document | methaville.docx |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | No access. |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
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