Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison (SAMBA)
Alcohol Dependence
About this trial
This is an interventional health services research trial for Alcohol Dependence focused on measuring Detoxification, Outpatient, Advanced Nursing, Health Services
Eligibility Criteria
Inclusion Criteria:
- DSM-IV-Tr criteria for alcohol dependence
- Clinical indication for alcohol detoxification
- Social Insurance
- Signed Consent Form for participation
Exclusion Criteria:
- Previous history of seizures
- previous history of delirium tremens
- acute or chronic liver failure
- contraindication for using diazepam
- average daily alcohol use of 300g of ethanol
- SADQ score of 30 or more
- chronic treatment with baclofen or disulfiram
- current DMS-IV-Tr criteria for major depressive episode, or lifelong history of bipolar or psychotic disorder
- any physical, cognitive, or psychiatric disorder that expose the subjects to enhanced risks (at the discretion of the investigator)
- previous participation in the SAMBA study
- social isolation of homelessness (at the discretion of the investigator)
- pregnancy or breastfeeding
- guardianship or curatorship
- previous participation in a biomedical study over the previous month
Sites / Locations
- CH Beziers
- CH Boulogne
- CHU Brest
- CHU Clermont-Ferrand
- Csapa Anpaa63
- CHU Créteil
- CH Dunkerque
- CHU Grenoble
- CH Lens - CSAPA Le Square
- CSAPA CHRU - Le PARI
- CH Limoux
- CSAPA Arc-en-Ciel
- CHU Nancy
- CHU Nantes
- Les Apsyades
- Centre LOGOS
- CH Perpignan
- Csapa Anpaa66
- CH Roubaix
- CSAPA La Trame - ANPAA59
- CHU Rouen
- CH du Rouvray
- CH Alpes-Isère
- CHU Strasbourg
- CH Tourcoing
- CH Troyes
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Advanced Nurse (AN)
General Practitioner (GP)
The outpatient detoxication procedure will be entirely managed by an advanced nurse team, using a predefined protocol decision algorithm. The protocol allows that the AN team autonomously manages the diazepam dosing during the detox period. Addiction physicians only intervenes in case of severe withdrawal symptoms or serious adverse events.
The outpatient detoxication procedure is entrusted to a GP who will manage patients and diazepam dosing as he/she thinks best ("as usual" control group)