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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome

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.

Detailed Summary:

Alcohol withdrawal syndrome (AWS) is a frequent and potentially fatal outcome. It is crucial to treat AWS in order to reduce symptoms severity, to prevent severe complications and to increase patient motivation to maintain long-term alcohol abstinence. Clarify the relevance of oral magnesium supplementation as a routine adjuvant therapy of AWS can give rise to a major evolution of guidelines regarding management of alcohol use disorder and make AWS more comfortable for hundred thousand patients.

Magnesium acts as a competitor of glutamate on NMDA receptor binding site, limiting glutamate toxicity leading to AWS. Previous findings suggested a correlation between AWS intensity and hypomagnesaemia degree, and an increased risk of severe AWS (i.e. delirium tremens and seizure) when there is deep depletion. In addition to magnesium role as a glutamatergic modulator via an NMDA-receptor antagonism activity, magnesium may also modulate GABAergic neurotransmission and affect numerous transduction pathways, including proteinkinase C, possibly influencing the access of corticosteroids to the brain.

Moreover, magnesium has been found to be a cofactor required for thiamine-dependent enzymes whereas thiamine supplementation is crucial to prevent from Wernicke's encephalopathy in the treatment of AWS. Finally, magnesium supplementation could help to reduce benzodiazepines use.

The primary endpoint is the between-group absolute difference of the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) score change from baseline, 3 days after randomization.

The secondary endpoints are:

a Total benzodiazepine consumption compared between experimental and control groups thr
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study [ Time Frame: 15 days after randomization ]
  • 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 ]
  • The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups [ Time Frame: 15 days after randomization ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Patient Satisfaction Questionnaire-18 scores at the last follow-up point compared between experimental and control groups [ Time Frame: 15 days after randomization ]
  • Total plasmatic 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 ]
  • Rate of all adverse events occurred during the study and compare their incidence between intervention and control groups [ Time Frame: 15 days after randomization ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: January 3, 2017
Date Started: March 2017
Date Completion: March 2019
Last Updated: January 24, 2017
Last Verified: January 2017