Self-estimates and Objective Blood Alcohol Concentration in Emergency Department

Alcohol Use Disorder Clinical Trial

— SEOBACED  

Official title:

Self-estimates and Objective Measurement of Blood Alcohol Concentration in Patients With Alcohol Intoxication Presenting to an Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998397
• Other study ID #: PI2018_843_0009
• Status: Completed
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: June 18, 2020

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Blood Alcohol Content
• Emergencies

Intervention

Biological:
• blood alcohol concentration withdrawal
The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day =0 (day of patient inclusion)
Secondary	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)	Day =0 (day of patient inclusion)
Secondary	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)	Day =0 (day of patient inclusion)
Secondary	Measure motivation to change during the first interview at the Emergency Department	Measure motivation to change during the first interview at the Emergency Department	Day =0 (day of patient inclusion)
Secondary	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	six months following the first interview at the Emergency Department