EUCTR2016-002072-26-FR进行中（未招募）1 期
Multicenter randomized placebo controlled trial assessing the efficacy of oral adjuvant magnesium supplementation in the treatment of alcohol withdrawal syndrome. - MAGMA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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