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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033823
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Syndrome Drug: Magnesium Drug: Placebo Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: Intervention
Usual care (i.e. without any restriction of drug therapy) plus oral tablet magnesium supplementation: 426.6mg of magnesium per day three times daily (i.e. 142.2 mg for each shot) throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used (i.e. 189.6mg).
Drug: Magnesium
Usual care (i.e. without any restriction of drug therapy) plus oral tablet magnesium supplementation: 426.6mg of magnesium per day three times daily (i.e. 142.2 mg for each shot) throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used (i.e. 189.6mg).

Placebo Comparator: Control
Usual care (i.e. without any restriction of drug therapy) plus oral placebo, totally similar to the verum, three times daily throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used.
Drug: Placebo Oral Tablet
Usual care (i.e. without any restriction of drug therapy) plus oral placebo, totally similar to the verum, three times daily throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used.
Other Name: Placebo




Primary Outcome Measures :
  1. Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline [ Time Frame: 3 days after randomization ]

Secondary Outcome Measures :
  1. Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study [ Time Frame: 15 days after randomization ]
  2. The delay compared between experimental and control groups until having a total score of 0 at the CIWA-Ar [ Time Frame: 15 days after randomization ]
  3. The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups [ Time Frame: 15 days after randomization ]
  4. Between-group absolute difference of the CIWA-Ar score change from baseline, considering two subgroups: score at the Charlson Comorbidity Index (CCI) min-score at the CCI median versus score score at the CCI median-score at the CCI min [ Time Frame: 3 days after randomization ]
  5. Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline considering two subgroups: 18-59 years versus 60-75 years [ Time Frame: 3 days after randomization ]
  6. The number of participants who left the hospital against medical advice during the study compared between intervention and control groups [ Time Frame: 15 days after randomization ]
  7. The number of participants who made an appointment in an addiction unit during the study compared between intervention and control groups after stratification following alcohol use disorder (AUD) duration and number of previous addiction healthcare [ Time Frame: 15 days after randomization ]
  8. Patient Satisfaction Questionnaire-18 scores at the last follow-up point compared between experimental and control groups [ Time Frame: 15 days after randomization ]
  9. Total plasmatic or serum magnesium concentration changes between baseline,3 days after baseline, and 7 days after baseline, compared between intervention and control groups [ Time Frame: 3 days and 7 days after randomization ]
  10. Rate of all adverse events occurred during the study and compare their incidence between intervention and control groups [ Time Frame: 15 days after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033823


Contacts
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Contact: Guillaume Airagnes, M.D. 01.56.09.56.19 ext +33 guillaume.airagnes@aphp.fr
Contact: Frédéric Limosin, M.D., Ph.D. 01.58.00.44.21 ext +33 frederic.limosin@aphp.fr

Locations
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France
Hôpital Louis Mourier, AP-HP Recruiting
Colombes, Ile-de-France, France, 92700
Contact: Caroline Dubertret, MD       caroline.dubertret@aphp.fr   
Clinique des Platanes Terminated
Epinay sur Seine, Ile-de-France, France, 93800
Hôpital Corentin Celton, AP-HP Recruiting
Issy-les-Moulineaux, Ile-de-France, France, 92130
Contact: Frédéric Limosin, MD       frederic.limosin@aphp.fr   
Institut MGEN de la Verriere Terminated
Le Mesnil Saint Denis, Ile-de-France, France, 78322
Institut MGEN la Verriere-service SSR addictologie Recruiting
Le Mesnil saint Denis, Ile-de-France, France, 78322
Contact: Cécile Maunand, MD       cmaunand@mgen.fr   
Clinique des maladies mentales et de l'encéphale Recruiting
Paris, Ile-de-France, France, 75014
Contact: Philipp Gorwood, MD       p.gorwood@ch-sainte-anne.fr   
Hôpital Européen Georges Pompidou-Service de chirugie orthopédique, AP-HP Terminated
Paris, Ile-de-France, France, 75015
Hôpital Européen Georges Pompidou-Service de médecine interne, AP-HP Recruiting
Paris, Ile-de-France, France, 75015
Contact: Jacques Pouchot, MD       jacques.pouchot@aphp.fr   
Hôpital européen Georges-Pompidou-Service hépato-gastroentérologie Recruiting
Paris, Ile-de-France, France, 75015
Contact: Agathe Ravaux, MD       agathe.ravaux@aphp.fr   
Centre Hospitalier des quatre villes Terminated
Sevres, Ile-De-France, France, 92310
Hôpital Emile ROUX Recruiting
Limeil-Brévannes, France
Contact: Jean-Baptiste Trabut, MD       jean-baptiste.trabut@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Frédéric Limosin, M.D., Ph.D. Assistance Publique-Hôpitaux de Paris (AP-HP)
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03033823    
Other Study ID Numbers: P150939
2016-002072-26 ( EudraCT Number )
PHRC ( Other Grant/Funding Number: 15-613 )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alcoholism
Delirium
Magnesium Deficiency
Additional relevant MeSH terms:
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Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders