Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison

Alcohol Dependence Clinical Trial

— SAMBA  

Official title:

Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03056365
• Other study ID #: 2015_09
• Secondary ID: 2015-A01936-43PR
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Procedure:
• Advanced Nurse (AN)
Protocoled AN-based management of detox
• General Practitioner (GP)
'As usual' medical management of detox

Locations

Country	Name	City	State
France	CH Beziers	Beziers
France	CH Boulogne	Boulogne
France	CHU Brest	Brest
France	CHU Clermont-Ferrand	Clermont Ferrand
France	Csapa Anpaa63	Clermont Ferrand
France	CHU Créteil	Creteil
France	CH Dunkerque	Dunkerque
France	CHU Grenoble	Grenoble
France	CH Lens - CSAPA Le Square	Lens
France	CSAPA CHRU - Le PARI	Lille
France	CH Limoux	Limoux
France	CSAPA Arc-en-Ciel	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Les Apsyades	Nantes
France	Centre LOGOS	Nimes
France	CH Perpignan	Perpignan
France	Csapa Anpaa66	Perpignan
France	CH Roubaix	Roubaix
France	CSAPA La Trame - ANPAA59	Roubaix
France	CHU Rouen	Rouen
France	CH du Rouvray	Rouvray
France	CH Alpes-Isère	Saint-Egrève
France	CHU Strasbourg	Strasbourg
France	CH Tourcoing	Tourcoing
France	CH Troyes	Troyes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients considered in failure of outpatient alcohol detoxification period	Hospitalization required (any cause) across the 15 days following the detox start	15 days
Secondary	The total costs for each arm by cost-minimization	All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management	during the 15 days of the outpatient alcohol detoxification
Secondary	Number of patients reporting at least one recovery in alcohol consumption	alcohol consumption obtained from A-TLFB data	during the 15 days of the outpatient alcohol detoxification
Secondary	Number of patients reporting at least one high alcohol intake	High alcohol intake defined by consumption of more than 5 standard drinks per day	during the 15 days of the outpatient alcohol detoxification
Secondary	Number of patients with adverse events		during the 15 days of the outpatient alcohol detoxification