NCT03033823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2017

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

2.9 years

First QC Date

January 3, 2017

Last Update Submit

December 20, 2021

Conditions

Alcohol Withdrawal Syndrome

Keywords

AlcoholismDeliriumMagnesium Deficiency

Outcome Measures

Primary Outcomes (1)

  • Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline

    3 days after randomization

Secondary Outcomes (10)

  • Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study

    15 days after randomization

  • The delay compared between experimental and control groups until having a total score of 0 at the CIWA-Ar

    15 days after randomization

  • The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups

    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

    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

    3 days after randomization

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

MagnesiumDRUG

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).

Intervention
Placebo Oral TabletDRUG

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.

Also known as: Placebo
Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Psychiatric disorder requiring hospitalization or specific cares in emergency (e.g. suicidal crisis, acute psychotic episode);
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Emile ROUX

Limeil-Brévannes, France

Location

Hôpital Louis Mourier, AP-HP

Colombes, Île-de-France Region, 92700, France

Location

Clinique des Platanes

Épinay-sur-Seine, Île-de-France Region, 93800, France

Location

Hôpital Corentin Celton, AP-HP

Issy-les-Moulineaux, Île-de-France Region, 92130, France

Location

Institut MGEN de la Verriere

Le Mesnil-Saint-Denis, Île-de-France Region, 78322, France

Location

Institut MGEN la Verriere-service SSR addictologie

Le Mesnil-Saint-Denis, Île-de-France Region, 78322, France

Location

Clinique des maladies mentales et de l'encéphale

Paris, Île-de-France Region, 75014, France

Location

Hôpital Européen Georges Pompidou-Service de chirugie orthopédique, AP-HP

Paris, Île-de-France Region, 75015, France

Location

Hôpital Européen Georges Pompidou-Service de médecine interne, AP-HP

Paris, Île-de-France Region, 75015, France

Location

Hôpital européen Georges-Pompidou-Service hépato-gastroentérologie

Paris, Île-de-France Region, 75015, France

Location

Centre Hospitalier des quatre villes

Sèvres, Île-de-France Region, 92310, France

Location

MeSH Terms

Conditions

AlcoholismDeliriumMagnesium Deficiency

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Frédéric Limosin, M.D., Ph.D.

    Assistance Publique-Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 27, 2017

Study Start

November 16, 2017

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)