Alcohol DependenceSAMBANCT03056365
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
A study testing Advanced Nurse (AN) and General Practitioner (GP) in people with Alcohol Dependence, run by University Hospital, Lille at 26 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Advanced Nurse (AN) and General Practitioner (GP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 26 sitesFrance
- Study dates
- 1 Jan 2017to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV-Tr criteria for alcohol dependence
- Clinical indication for alcohol detoxification
- Social Insurance
- Signed Consent Form for participation
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CH Beziers
Béziers
CH Boulogne
Boulogne
CHU Brest
Brest
CHU Clermont-Ferrand
Clermont-Ferrand
Csapa Anpaa63
Clermont-Ferrand
CHU Créteil
Créteil
CH Dunkerque
Dunkirk
CHU Grenoble
Grenoble
CH Lens - CSAPA Le Square
Lens
CSAPA CHRU - Le PARI
Lille
CH Limoux
Limoux
CSAPA Arc-en-Ciel
Montpellier
CHU Nancy
Nancy
CHU Nantes
Nantes
Les Apsyades
Nantes
Centre LOGOS
Nîmes
CH Perpignan
Perpignan
Csapa Anpaa66
Perpignan
CH Roubaix
Roubaix
CSAPA La Trame - ANPAA59
Roubaix
CHU Rouen
Rouen
CH du Rouvray
Rouvray
CH Alpes-Isère
Saint-Egrève
CHU Strasbourg
Strasbourg
CH Tourcoing
Tourcoing
CH Troyes
Troyes
About this study
Official title: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
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.
- Conditions
- Alcohol Dependence
- Being tested
- Advanced Nurse (AN), General Practitioner (GP)
- Keywords
- Detoxification, Outpatient, Advanced Nursing, Health Services
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Nurse (AN)Procedure or surgery
Protocoled AN-based management of detox
General Practitioner (GP)Procedure or surgery
'As usual' medical management of detox
| Study group | Role | What they receive |
|---|---|---|
| Advanced Nurse (AN) | Experimental | 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. Receives: Procedure: Advanced Nurse (AN) |
| General Practitioner (GP) | Active comparator | 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) Receives: Procedure: General Practitioner (GP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients considered in failure of outpatient alcohol detoxification period
Hospitalization required (any cause) across the 15 days following the detox start
Measured: 15 days
Secondary outcomes (4)
The total costs for each arm by cost-minimization
All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management
Measured: during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one recovery in alcohol consumption
alcohol consumption obtained from A-TLFB data
Measured: during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one high alcohol intake
High alcohol intake defined by consumption of more than 5 standard drinks per day
Measured: during the 15 days of the outpatient alcohol detoxification
Number of patients with adverse events
Measured: during the 15 days of the outpatient alcohol detoxification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Jan 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Renaud JARDRI, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056365
- Sponsor's protocol ID
- 2015_09
- Other IDs
- 2015-A01936-43, PREPS_14-0209
- Acronym
- SAMBA
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2017
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
- ClinicalTrials.gov ID
- NCT03056365
- Acronym / sponsor ID
- SAMBA / 2015_09
- Conditions
- Alcohol Dependence
- Keywords
- Detoxification, Outpatient, Advanced Nursing, Health Services
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Nurse (AN) | Experimental | Procedure: Advanced Nurse (AN)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. |
| General Practitioner (GP) | Active comparator | Procedure: General Practitioner (GP)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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM-IV-Tr criteria for alcohol dependence
- Clinical indication for alcohol detoxification
- Social Insurance
- Signed Consent Form for participation
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Nurse (AN)Protocoled AN-based management of detox | Procedure or surgery | Advanced Nurse (AN) |
| General Practitioner (GP)'As usual' medical management of detox | Procedure or surgery | General Practitioner (GP) |
Primary outcome
Number of patients considered in failure of outpatient alcohol detoxification period
Time frame: 15 days
Hospitalization required (any cause) across the 15 days following the detox start
4 secondary outcomes
The total costs for each arm by cost-minimization
Time frame: during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one recovery in alcohol consumption
Time frame: during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one high alcohol intake
Time frame: during the 15 days of the outpatient alcohol detoxification
Number of patients with adverse events
Time frame: during the 15 days of the outpatient alcohol detoxification
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud JARDRI, MD, PhD principal investigator
University Hospital, Lille
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Nurse (AN) and General Practitioner (GP) in people with Alcohol Dependence, run by University Hospital, Lille at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients considered in failure of outpatient alcohol detoxification period (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.