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Self-estimates and Objective Blood Alcohol Concentration in Emergency Department (SEOBACED)
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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Use Disorder Blood Alcohol Content | Biological: blood alcohol concentration withdrawal | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department |
| Estimated Study Start Date : | June 18, 2019 |
| Estimated Primary Completion Date : | June 18, 2020 |
| Estimated Study Completion Date : | June 18, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: patients with alcohol use disorders |
Biological: blood alcohol concentration withdrawal
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
|
| Experimental: patients without alcohol use disorders |
Biological: blood alcohol concentration withdrawal
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
|
- 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
- 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) ]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)
- 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) ]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)
- Measure motivation to change during the first interview at the Emergency Department [ Time Frame: Day =0 (day of patient inclusion) ]Measure motivation to change during the first interview at the Emergency Department
- 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 ]Measure motivation to change six months following the first interview at the Emergency Department
| Ages Eligible for Study: | 15 Years to 64 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
| Contact: Alain Dervaux, Pr | (33) 322668290 | dervaux.alain@chu-amiens.fr |
| Principal Investigator: | Alain Dervaux, Pr | CHU Amiens |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 21, 2019 | ||||
| First Posted Date ICMJE | June 26, 2019 | ||||
| Last Update Posted Date | June 26, 2019 | ||||
| Estimated Study Start Date ICMJE | June 18, 2019 | ||||
| Estimated Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Self-estimates and Objective Blood Alcohol Concentration in Emergency Department | ||||
| Official Title ICMJE | Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department | ||||
| Brief 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. 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) |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
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| Intervention ICMJE | Biological: blood alcohol concentration withdrawal
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 18, 2020 | ||||
| Estimated Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 15 Years to 64 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03998397 | ||||
| Other Study ID Numbers ICMJE | PI2018_843_0009 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire, Amiens | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire, Amiens | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Centre Hospitalier Universitaire, Amiens | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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