A

Phase 1

Active, not recruiting

• Conditions: Patients experiencing an alcohol withdrawal syndrome.; MedDRA version: 21.0Level: PTClassification code 10053164Term: Alcohol withdrawal syndromeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2016-002072-26-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all the following criteria:
-Adult inpatients, men and women (i.e. age>18 years and <75 years) ;
-Current AWS according to DSM-5 criteria;
-Score at the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) >8;
-Written informed consent to participate in the study.
-Affiliation to the French Social Security Health Care plan

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Non-inclusion criteria
-Age less than 18 or greater than 75;
-Hemodynamic failure;
-Arythmia;
-Lack of fulfilling AWS criteria according to DSM-5;
-Score at the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) <=8;
-Other current substance use disorder regarding DSM-5 criteria, including benzodiazepine substance use disorder and except for tobacco. In addition to benzodiazepine substance use disorder, following criteria of inappropriate use of benzodiazepine and related-benzodiazepine hypnotics are also considered as non-inclusion criteria: - over-the-counter consumption; - consumption outside the indications of marketing authorization; - excessive dosage or duration regarding guidelines. Licit or illicit substance consumption that is not fulfilling substance use disorder DSM-5 criteria is not considered as a non-inclusion criterion (e.g. cannabis consumption without sufficient criteria to diagnose substance use disorder regarding DSM-5 criteria);
-Pregnancy or breast-feeding;
-Unable to take oral medications;
-Creatinine clearance <30mL/min according to the Cockcroft-Gault Equation;
-Cognitive disorders that impair the informed consent, including dementia (except for acute withdrawal delirium);
-Psychiatric disorder requiring hospitalization or specific cares in emergency (e.g. suicidal crisis, acute psychotic episode);
-Magnesium supplementation (regardless the type of delivery) within 3 months prior to inclusion;
-Actual quinidine intake;
-No written informed consent to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified