ITMO public health
Last update : 10/22/2018 | Version : 1 | ID : 73282
| General | |
| Identification | |
| Detailed name | Cross-sectional study assessing the prevalence of co-addictions in subjects receiving opioid substitution treatment: determination of the clinical and pharmacological profile |
| Sign or acronym | OPAL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: authorisation No. 913237 / CCTIRS: No. 13.223 |
| General Aspects | |
| Medical area |
Biology Psychology and psychiatry |
| Health determinants |
Addictions Genetic |
| Keywords | Opioid dependence, opioid substitution treatment, psychoactive substance, pharmacokinetics, pharmacogenetics, polymorphism, cytochrome P450 2D6, addictions, pathological gambling |
| Scientific investigator(s) (Contact) | |
| Name of the director | Grall-Bronnec |
| Surname | Marie |
| Address |
IFAC Batiment Louis Philippe Hopital St Jacques 85 rue St Jacques 44 093 Nantes cedex 01 |
| Phone | + 33 (0)2 40 84 61 16 |
| marie.bronnec@chu-nantes.fr | |
| Unit | Addiction department of the CHU de Nantes / UIC 18 Clinical Investigation Unit: Behavioural addictions and complex mood disorders / EA 4275 SPHERE |
| Organization | Chu de Nantes |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Multicentric study in collaboration with the CHU de Brest, CHU d’Angers, CH de Morlaix, CH G. Régnier de Rennes, CSAPA "Le Triangle" (Nantes), "La métairie" (La Roche S / Yon) And "La Rose des Vents" (St Nazaire), the SMPR in Nantes and the Addictions Network of the Nantes Region (RTRN) |
| Funding | |
| Funding status |
Public |
| Details | Interministerial Mission for Combating Drugs and Addictive Behaviours (MILDECA) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Chu de Nantes |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
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 |
No |
| Additional information regarding sample selection. | The study will focus on patients with a prescribed OST due to opioid dependence, whether the OST is methadone, buprenorphine (+/- naloxone) or a morphine-based drug. Recruitment is multicentric (10 centres in the western region participated in this study) |
| Database objective | |
| Main objective | assess the current prevalence of addictive comorbidities in opioid-dependent subjects who have been receiving opioid substitution therapy (OST) for at least 6 months. |
| Inclusion criteria |
Adult
Treatment with methadone or buprenorphine (+/- naloxone) or morphine as a substitute, prescribed for opioid dependence OST established for at least 6 months Incarceration of less than one month if monitored by a Regional Medical and Psychological Service (SMPR) in prison Good understanding of French, knowing how to read and write it. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Pathology | V - Mental and behavioural disorders |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Nantes, Brest, Morlaix, Angers, Rennes, St Nazaire |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 11/2013 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 263 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | collection of data in consultation by the physician and/or nurse |
| Quality procedure(s) used | Verification of data by a Clinical Study Technician and the consistency of data by the data cell when entering it into the computer database |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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