Self-estimates and Objective Blood Alcohol Concentration in Emergency Department (SEOBACED)

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day =0 (day of patient inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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
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
Measure motivation to change six months following the first interview at the Emergency Department
six months following the first interview at the Emergency Department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Alain Dervaux, Pr, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2018_843_0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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