Alcohol Use DisorderSEOBACEDNCT03998397
Self-estimates and Objective Blood Alcohol Concentration in Emergency Department
A study testing blood alcohol concentration withdrawal in people with Alcohol Use Disorder and Blood Alcohol Content, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Many patients presenting in Emergency Department (ED) present alcohol acute intoxication. Some previous studies in general population found that young people under- or over-estimated of blood alcohol concentration (BAC). The hypothesis of the study is that self-estimation of BAC by the patient is under-estimated. Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Alcohol Use Disorder, Blood Alcohol Content
- What is being tested?
- blood alcohol concentration withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2019to 18 Jun 2020
- 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 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients admitted in Emergency Department while intoxicated will be included in the study, including patients with or without alcohol use disorders according to DSM-5 classification.
- aged 15-64 years old
- patients who will be orally informed and receive a written summary
- blood alcohol concentration of 60mg/dl or higher
- Patients not opposed to participating in the study, who have received an oral and written information
Who cannot join
- Drug intoxication (cannabis, opiates, amphetamines, cocaine), psychotropic medication intoxication (benzodiazepines, antipsychotics), primary neurologic conditions, mental retardation, dementia, amnestic disorders, mental disorders due to a general, medical condition and substance-induced psychotic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department
Many patients presenting in Emergency Department (ED) present alcohol acute intoxication. Some previous studies in general population found that young people under- or over-estimated of blood alcohol concentration (BAC). The hypothesis of the study is that self-estimation of BAC by the patient is under-estimated. Moreover, comparing self-estimation of BAC and objective measure of BAC, which is routinely performed in ED, could increase in patients the awareness of the disorders, increase motivation to change of the patient, and increase the rates of seeking-treatment six months after the first evaluation, in particular in patients with alcohol use disorders.
To the investigators knowledge, there is no study investigating self-estimation, compared to objective measurement of blood alcohol concentration in patients with alcohol intoxication presenting to an Emergency Department (ED). The study will assess blood alcohol concentration and self-estimates of BAC, using the Subjective Effects of Alcohol Scale for Measuring Subjective Response to Alcohol in 100 patients with or without alcohol use disorders according to DSM-5 classification (using MINI scale and Alcohol Use Disorders Identification Test (AUDIT)
- Conditions
- Alcohol Use Disorder, Blood Alcohol Content
- Being tested
- blood alcohol concentration withdrawal
- Keywords
- blood alcohol concentration, Emergency Department, Alcohol use disorders
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood alcohol concentration withdrawalBiological
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
| Study group | Role | What they receive |
|---|---|---|
| patients with alcohol use disorders | Experimental | Not described Receives: Biological: blood alcohol concentration withdrawal |
| patients without alcohol use disorders | Experimental | Not described Receives: Biological: blood alcohol concentration withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration
Comparison of real blood alcohol concentration and self-estimated blood alcohol concentration
Measured: Day =0 (day of patient inclusion)
Secondary outcomes (4)
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient with alcohol use disorders
Comparison of real blood alcohol concentration and self-estimated blood alcohol concentration with alcohol use disorders according DSM-5 classification (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Measured: Day =0 (day of patient inclusion)
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient without alcohol use disorders
Comparison of real blood alcohol concentration and self-estimated blood alcohol concentration without alcohol use disorders according DSM-5 classification (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Measured: Day =0 (day of patient inclusion)
Measure motivation to change during the first interview at the Emergency Department
Measure motivation to change during the first interview at the Emergency Department
Measured: Day =0 (day of patient inclusion)
Measure motivation to change six months following the first interview at the Emergency Department
Measure motivation to change six months following the first interview at the Emergency Department
Measured: six months following the first interview at the Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start18 Jun 2019
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Dervaux, Pr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998397
- Sponsor's protocol ID
- PI2018_843_0009
- Acronym
- SEOBACED
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DOI:10.1016/j.euroneuro.2020.09.032 November 2020European Neuropsychopharmacology 40(4):S20 P.029 Self-estimation of blood alcohol concentration in patients admitted for acute alcohol intoxication in emergency department
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department
- ClinicalTrials.gov ID
- NCT03998397
- Acronym / sponsor ID
- SEOBACED / PI2018_843_0009
- Conditions
- Alcohol Use Disorder, Blood Alcohol Content
- Keywords
- blood alcohol concentration, Emergency Department, Alcohol use disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 26 Jun 2019 (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.
Many patients presenting in Emergency Department (ED) present alcohol acute intoxication. Some previous studies in general population found that young people under- or over-estimated of blood alcohol concentration (BAC). The hypothesis of the study is that self-estimation of BAC by the patient is under-estimated. Moreover, comparing self-estimation of BAC and objective measure of BAC, which is routinely performed in ED, could increase in patients the awareness of the disorders, increase motivation to change of the patient, and increase the rates of seeking-treatment six months after the first evaluation, in particular in patients with alcohol use disorders.
To the investigators knowledge, there is no study investigating self-estimation, compared to objective measurement of blood alcohol concentration in patients with alcohol intoxication presenting to an Emergency Department (ED). The study will assess blood alcohol concentration and self-estimates of BAC, using the Subjective Effects of Alcohol Scale for Measuring Subjective Response to Alcohol in 100 patients with or without alcohol use disorders according to DSM-5 classification (using MINI scale and Alcohol Use Disorders Identification Test (AUDIT)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with alcohol use disorders | Experimental | Biological: blood alcohol concentration withdrawal |
| patients without alcohol use disorders | Experimental | Biological: blood alcohol concentration withdrawal |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients admitted in Emergency Department while intoxicated will be included in the study, including patients with or without alcohol use disorders according to DSM-5 classification.
- aged 15-64 years old
- patients who will be orally informed and receive a written summary
- blood alcohol concentration of 60mg/dl or higher
- Patients not opposed to participating in the study, who have received an oral and written information
Key exclusion criteria (1 listed)
- Drug intoxication (cannabis, opiates, amphetamines, cocaine), psychotropic medication intoxication (benzodiazepines, antipsychotics), primary neurologic conditions, mental retardation, dementia, amnestic disorders, mental disorders due to a general, medical condition and substance-induced psychotic disorders.
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 |
|---|---|---|
| blood alcohol concentration withdrawalThe blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department | Biological | patients with alcohol use disorders, patients without alcohol use disorders |
Primary outcome
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration
Time frame: Day =0 (day of patient inclusion)
Comparison of real blood alcohol concentration and self-estimated blood alcohol concentration
4 secondary outcomes
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient with alcohol use disorders
Time frame: Day =0 (day of patient inclusion)
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient without alcohol use disorders
Time frame: Day =0 (day of patient inclusion)
Measure motivation to change during the first interview at the Emergency Department
Time frame: Day =0 (day of patient inclusion)
Measure motivation to change six months following the first interview at the Emergency Department
Time frame: six months following the first interview at the Emergency Department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publicationDOI:10.1016/j.euroneuro.2020.09.032 November 2020European Neuropsychopharmacology 40(4):S20 P.029 Self-estimation of blood alcohol concentration in patients admitted for acute alcohol intoxication in emergency department
- Individual participant dataSharing planned: No
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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.
Alain Dervaux, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood alcohol concentration withdrawal in people with Alcohol Use Disorder and Blood Alcohol Content, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration (time frame: Day =0 (day of patient inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998397, which also lists 1 linked publication.
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 19 Nov 2025.