MAGnesium Adjunction in Alcohol Withdrawal Syndrome: a Multicenter Assessment (MAGMA) (NCT03033823) | Clinical Trial Compass
CompletedPhase 3
MAGnesium Adjunction in Alcohol Withdrawal Syndrome: a Multicenter Assessment (MAGMA)
France105 participantsStarted 2017-11-16
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline