MAGnesium Adjunction in Alcohol Withdrawal Syndrome: a Multicenter Assessment (MAGMA)

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for decreasing intensity of alcohol withdrawal symptoms among inpatients requiring pharmacological treatment of their AWS. This double blind randomized multicenter clinical trial planned to treat half of participants as usal plus placebo and the other half as usual plus magnesium.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France

Criteria

Inclusion 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.

Exclusion 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;

• Benzodiazepine misuse according to the opinion of the investigator;

• Substance use disorder according to the opinion of the investigator, regarding licit and illicit substances, except for tobacco;

• Pregnancy or breast-feeding;

• Unable to take oral medications;

• Creatinine clearance < 45mL/min less than 6 months old. If there is no dosage in the last 6 months, creatinine clearance must be <30mL/min at inclusion (creatinine clearance computed according to the Cockcroft-Gault Equation);

• Cognitive disorders already known at inclusion that impair the informed consent, including dementia (except for acute withdrawal delirium), according to the opinion of the investigator;

• 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;

• Patient under tutorship or curatorship;

• Hypersensitivity to Magnespasmyl® or to any of its excipients (including sucrose) or to lactose (placebo excipient).