Self-estimates and Objective Blood Alcohol Concentration in Emergency Department (SEOBACED)
Primary Purpose
Alcohol Use Disorder, Blood Alcohol Content
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood alcohol concentration withdrawal
Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder focused on measuring blood alcohol concentration, Emergency Department, Alcohol use disorders
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with alcohol use disorders
patients without alcohol use disorders
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
Measure motivation to change during the first interview at the Emergency Department
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
Measure motivation to change six months following the first interview at the Emergency Department
Full Information
NCT ID
NCT03998397
First Posted
June 21, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03998397
Brief Title
Self-estimates and Objective Blood Alcohol Concentration in Emergency Department
Acronym
SEOBACED
Official Title
Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Blood Alcohol Content
Keywords
blood alcohol concentration, Emergency Department, Alcohol use disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with alcohol use disorders
Arm Type
Experimental
Arm Title
patients without alcohol use disorders
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood alcohol concentration withdrawal
Intervention Description
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
Primary Outcome Measure Information:
Title
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration
Description
Comparison of real blood alcohol concentration and self-estimated blood alcohol concentration
Time Frame
Day =0 (day of patient inclusion)
Secondary Outcome Measure Information:
Title
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient with alcohol use disorders
Description
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)
Time Frame
Day =0 (day of patient inclusion)
Title
Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient without alcohol use disorders
Description
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)
Time Frame
Day =0 (day of patient inclusion)
Title
Measure motivation to change during the first interview at the Emergency Department
Description
Measure motivation to change during the first interview at the Emergency Department
Time Frame
Day =0 (day of patient inclusion)
Title
Measure motivation to change six months following the first interview at the Emergency Department
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Dervaux, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-estimates and Objective Blood Alcohol Concentration in Emergency Department
We'll reach out to this number within 24 hrs