NCT03998397

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

June 21, 2019

Last Update Submit

November 17, 2025

Conditions

Keywords

blood alcohol concentrationEmergency DepartmentAlcohol use disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mean change between real blood alcohol concentration and self-estimated blood alcohol concentration in patient with alcohol use disorders

    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

    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

    six months following the first interview at the Emergency Department

Study Arms (2)

patients with alcohol use disorders

EXPERIMENTAL
Biological: blood alcohol concentration withdrawal

patients without alcohol use disorders

EXPERIMENTAL
Biological: blood alcohol concentration withdrawal

Interventions

The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department

patients with alcohol use disorderspatients without alcohol use disorders

Eligibility Criteria

Age15 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

AlcoholismEmergencies

Interventions

Blood Specimen CollectionEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesAlcoholsOrganic Chemicals

Study Officials

  • Alain Dervaux, Pr

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 26, 2019

Study Start

June 18, 2019

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations