Clinical trial NCT03056365: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
Official title: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Detoxification
Outpatient
Advanced Nursing
Health Services
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-02-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group).

In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.


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

Primary outcomes:
measure: Number of patients considered in failure of outpatient alcohol detoxification period
timeFrame: 15 days
Secondary outcomes:
measure: The total costs for each arm by cost-minimization
timeFrame: during the 15 days of the outpatient alcohol detoxification
measure: Number of patients reporting at least one recovery in alcohol consumption
timeFrame: during the 15 days of the outpatient alcohol detoxification
measure: Number of patients reporting at least one high alcohol intake
timeFrame: during the 15 days of the outpatient alcohol detoxification
measure: Number of patients with adverse events
timeFrame: during the 15 days of the outpatient alcohol detoxification
Other outcomes:
Locations:
city: Beziers
country: France
facility: CH Beziers
city: Boulogne
country: France
facility: CH Boulogne
city: Brest
country: France
facility: CHU Brest
city: Clermont Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont Ferrand
country: France
facility: Csapa Anpaa63
city: Creteil
country: France
facility: CHU Créteil
city: Dunkerque
country: France
facility: CH Dunkerque
city: Grenoble
country: France
facility: CHU Grenoble
city: Lens
country: France
facility: CH Lens - CSAPA Le Square
city: Lille
country: France
facility: CSAPA CHRU - Le PARI
city: Limoux
country: France
facility: CH Limoux
city: Montpellier
country: France
facility: CSAPA Arc-en-Ciel
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Les Apsyades
city: Nimes
country: France
facility: Centre LOGOS
city: Perpignan
country: France
facility: CH Perpignan
city: Perpignan
country: France
facility: Csapa Anpaa66
city: Roubaix
country: France
facility: CH Roubaix
city: Roubaix
country: France
facility: CSAPA La Trame - ANPAA59
city: Rouen
country: France
facility: CHU Rouen
city: Rouvray
country: France
facility: CH du Rouvray
city: Saint-Egrève
country: France
facility: CH Alpes-Isère
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tourcoing
country: France
facility: CH Tourcoing
city: Troyes
country: France
facility: CH Troyes
Study officials:
affiliation: University Hospital, Lille
name: Renaud JARDRI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: