<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03033823</url>
  </required_header>
  <id_info>
    <org_study_id>P150939</org_study_id>
    <secondary_id>2016-002072-26</secondary_id>
    <secondary_id>PHRC</secondary_id>
    <nct_id>NCT03033823</nct_id>
  </id_info>
  <brief_title>MAGnesium Adjunction in Alcohol Withdrawal Syndrome: a Multicenter Assessment (MAGMA)</brief_title>
  <acronym>MAGMA</acronym>
  <official_title>Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for&#xD;
      decreasing intensity of alcohol withdrawal symptoms among inpatients requiring&#xD;
      pharmacological treatment of their AWS. This double blind randomized multicenter clinical&#xD;
      trial planned to treat half of participants as usal plus placebo and the other half as usual&#xD;
      plus magnesium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol withdrawal syndrome (AWS) is a frequent and potentially fatal outcome. It is crucial&#xD;
      to treat AWS in order to reduce symptoms severity, to prevent severe complications and to&#xD;
      increase patient motivation to maintain long-term alcohol abstinence. Clarify the relevance&#xD;
      of oral magnesium supplementation as a routine adjuvant therapy of AWS can give rise to a&#xD;
      major evolution of guidelines regarding management of alcohol use disorder and make AWS more&#xD;
      comfortable for hundred thousand patients.&#xD;
&#xD;
      Magnesium acts as a competitor of glutamate on NMDA receptor binding site, limiting glutamate&#xD;
      toxicity leading to AWS. Previous findings suggested a correlation between AWS intensity and&#xD;
      hypomagnesaemia degree, and an increased risk of severe AWS (i.e. delirium tremens and&#xD;
      seizure) when there is deep depletion. In addition to magnesium role as a glutamatergic&#xD;
      modulator via an NMDA-receptor antagonism activity, magnesium may also modulate GABAergic&#xD;
      neurotransmission and affect numerous transduction pathways, including proteinkinase C,&#xD;
      possibly influencing the access of corticosteroids to the brain.&#xD;
&#xD;
      Moreover, magnesium has been found to be a cofactor required for thiamine-dependent enzymes&#xD;
      whereas thiamine supplementation is crucial to prevent from Wernicke's encephalopathy in the&#xD;
      treatment of AWS. Finally, magnesium supplementation could help to reduce benzodiazepines&#xD;
      use.&#xD;
&#xD;
      The primary endpoint is the between-group absolute difference of the revised clinical&#xD;
      institute withdrawal assessment for alcohol scale (CIWA-Ar) score change from baseline, 3&#xD;
      days after randomization.&#xD;
&#xD;
      The secondary endpoints are:&#xD;
&#xD;
      a Total benzodiazepine consumption compared between experimental and control groups&#xD;
      throughout the duration of the study (i.e. 15 days); b Time required to obtain a total score&#xD;
      of 0 at the CIWA-Ar compared between experimental and control groups; c Rate of patients&#xD;
      experiencing seizures and delirium tremens during the study compared between intervention and&#xD;
      control groups; d Stratify results of the Primary endpoint following score at the Charlson&#xD;
      Comorbidity Index; e Stratify results of the Primary endpoint by age; f Number of&#xD;
      participants who left the hospital against medical advice during the study compared between&#xD;
      experimental and control groups; g Number of participants who made an appointment in an&#xD;
      addiction unit during the study (i.e. before the last follow-up point, 15 days after&#xD;
      baseline), compared between experimental and control groups after stratification following&#xD;
      AUD duration and number of previous addiction healthcare; h Patient Satisfaction&#xD;
      Questionnaire-18 (PSQ-18) scores at the last follow-up point (i.e. days after baseline)&#xD;
      compared between experimental and control groups; i Total plasmatic or serum magnesium&#xD;
      concentration changes between baseline, 3 days after baseline, and 7 days after baseline; j&#xD;
      Rate of all adverse events occurred during the study incidence compared between experimental&#xD;
      and control groups;&#xD;
&#xD;
      Practical procedure:&#xD;
&#xD;
      Patients recruited are inpatients, hospitalized whatever the main reason for hospitalization&#xD;
      (i.e. alcohol withdrawal syndrome or other reason). Inclusion visit starts with signature of&#xD;
      informed consent, then confirms the eligibility and finally, ends with randomization and&#xD;
      administration of the first dose of treatment. Patients are followed 15 days after baseline.&#xD;
      Total plasmatic or serum magnesium concentration is dosed at baseline, 3 days and 7 days. In&#xD;
      addition to CIWA-Ar and AUDIT, the following assessments are performed at baseline: Charlson&#xD;
      comorbidity index, DIGS, SCL-90, MINI. We will use tablets of 465.4 mg of magnesium lactate&#xD;
      dehydrate (Magnespasmyl©), which corresponds to 47.4mg of magnesium (i.e. 1.9mmol of&#xD;
      magnesium per tablet). These tablets will be prescribed as follows: 3 tablets three times per&#xD;
      day. In case of diarrhea, nearly half-dosage will be used until the end of the follow-up&#xD;
      (i.e. 189.6mg per day, 3 times a day as follows: 1 tablet, 2 tablets, 1 tablet). Patients&#xD;
      will be informed that treatment is to be taken during meals and to avoid sodas during the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline</measure>
    <time_frame>3 days after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The delay compared between experimental and control groups until having a total score of 0 at the CIWA-Ar</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>3 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>3 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants who left the hospital against medical advice during the study compared between intervention and control groups</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Questionnaire-18 scores at the last follow-up point compared between experimental and control groups</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total plasmatic or serum magnesium concentration changes between baseline,3 days after baseline, and 7 days after baseline, compared between intervention and control groups</measure>
    <time_frame>3 days and 7 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of all adverse events occurred during the study and compare their incidence between intervention and control groups</measure>
    <time_frame>15 days after randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Alcohol Withdrawal Syndrome</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium</intervention_name>
    <description>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).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult inpatients, men and women (i.e. age&gt;18 years and &lt;75 years) ;&#xD;
&#xD;
          -  Current AWS according to DSM-5 criteria;&#xD;
&#xD;
          -  Score at the revised clinical institute withdrawal assessment for alcohol scale&#xD;
             (CIWA-Ar) &gt;8;&#xD;
&#xD;
          -  Written informed consent to participate in the study;&#xD;
&#xD;
          -  Affiliation to the French Social Security Health Care plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 or greater than 75;&#xD;
&#xD;
          -  Hemodynamic failure;&#xD;
&#xD;
          -  Arythmia;&#xD;
&#xD;
          -  Lack of fulfilling AWS criteria according to DSM-5;&#xD;
&#xD;
          -  Score at the revised clinical institute withdrawal assessment for alcohol scale&#xD;
             (CIWA-Ar) &lt;=8;&#xD;
&#xD;
          -  Benzodiazepine misuse according to the opinion of the investigator;&#xD;
&#xD;
          -  Substance use disorder according to the opinion of the investigator, regarding licit&#xD;
             and illicit substances, except for tobacco;&#xD;
&#xD;
          -  Pregnancy or breast-feeding;&#xD;
&#xD;
          -  Unable to take oral medications;&#xD;
&#xD;
          -  Creatinine clearance &lt; 45mL/min less than 6 months old. If there is no dosage in the&#xD;
             last 6 months, creatinine clearance must be &lt;30mL/min at inclusion (creatinine&#xD;
             clearance computed according to the Cockcroft-Gault Equation);&#xD;
&#xD;
          -  Cognitive disorders already known at inclusion that impair the informed consent,&#xD;
             including dementia (except for acute withdrawal delirium), according to the opinion of&#xD;
             the investigator;&#xD;
&#xD;
          -  Psychiatric disorder requiring hospitalization or specific cares in emergency (e.g.&#xD;
             suicidal crisis, acute psychotic episode);&#xD;
&#xD;
          -  Magnesium supplementation (regardless the type of delivery) within 3 months prior to&#xD;
             inclusion;&#xD;
&#xD;
          -  Actual quinidine intake;&#xD;
&#xD;
          -  No written informed consent to participate in the study;&#xD;
&#xD;
          -  Patient under tutorship or curatorship;&#xD;
&#xD;
          -  Hypersensitivity to Magnespasmyl® or to any of its excipients (including sucrose) or&#xD;
             to lactose (placebo excipient).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Limosin, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique-Hôpitaux de Paris (AP-HP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Louis Mourier, AP-HP</name>
      <address>
        <city>Colombes</city>
        <state>Ile-de-France</state>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique des Platanes</name>
      <address>
        <city>Epinay sur Seine</city>
        <state>Ile-de-France</state>
        <zip>93800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Corentin Celton, AP-HP</name>
      <address>
        <city>Issy-les-Moulineaux</city>
        <state>Ile-de-France</state>
        <zip>92130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut MGEN de la Verriere</name>
      <address>
        <city>Le Mesnil Saint Denis</city>
        <state>Ile-de-France</state>
        <zip>78322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut MGEN la Verriere-service SSR addictologie</name>
      <address>
        <city>Le Mesnil saint Denis</city>
        <state>Ile-de-France</state>
        <zip>78322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique des maladies mentales et de l'encéphale</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou-Service de chirugie orthopédique, AP-HP</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou-Service de médecine interne, AP-HP</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital européen Georges-Pompidou-Service hépato-gastroentérologie</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier des quatre villes</name>
      <address>
        <city>Sevres</city>
        <state>Ile-De-France</state>
        <zip>92310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Emile ROUX</name>
      <address>
        <city>Limeil-Brévannes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcoholism</keyword>
  <keyword>Delirium</keyword>
  <keyword>Magnesium Deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03033823
org study id: P150939
secondary id: 2016-002072-26
secondary id: PHRC
nct id: NCT03033823
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
      throughout the duration of the study (i.e. 15 days); b Time required to obtain a total score
      of 0 at the CIWA-Ar compared between experimental and control groups; c Rate of patients
      experiencing seizures and delirium tremens during the study compared between intervention and
      control groups; d Stratify results of the Primary endpoint following score at the Charlson
      Comorbidity Index; e Stratify results of the Primary endpoint by age; f Number of
      participants who left the hospital against medical advice during the study compared between
      experimental and control groups; g Number of participants who made an appointment in an
      addiction unit during the study (i.e. before the last follow-up point, 15 days after
      baseline), compared between experimental and control groups after stratification following
      AUD duration and number of previous addiction healthcare; h Patient Satisfaction
      Questionnaire-18 (PSQ-18) scores at the last follow-up point (i.e. days after baseline)
      compared between experimental and control groups; i Total plasmatic or serum magnesium
      concentration changes between baseline, 3 days after baseline, and 7 days after baseline; j
      Rate of all adverse events occurred during the study incidence compared between experimental
      and control groups;

      Practical procedure:

      Patients recruited are inpatients, hospitalized whatever the main reason for hospitalization
      (i.e. alcohol withdrawal syndrome or other reason). Inclusion visit starts with signature of
      informed consent, then confirms the eligibility and finally, ends with randomization and
      administration of the first dose of treatment. Patients are followed 15 days after baseline.
      Total plasmatic or serum magnesium concentration is dosed at baseline, 3 days and 7 days. In
      addition to CIWA-Ar and AUDIT, the following assessments are performed at baseline: Charlson
      comorbidity index, DIGS, SCL-90, MINI. We will use tablets of 465.4 mg of magnesium lactate
      dehydrate (Magnespasmyl©), which corresponds to 47.4mg of magnesium (i.e. 1.9mmol of
      magnesium per tablet). These tablets will be prescribed as follows: 3 tablets three times per
      day. In case of diarrhea, nearly half-dosage will be used until the end of the follow-up
      (i.e. 189.6mg per day, 3 times a day as follows: 1 tablet, 2 tablets, 1 tablet). Patients
      will be informed that treatment is to be taken during meals and to avoid sodas during the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
measure: Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study
time frame: 15 days after randomization
measure: 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
measure: The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups
time frame: 15 days after randomization
measure: 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
measure: 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
measure: 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
measure: 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
measure: Patient Satisfaction Questionnaire-18 scores at the last follow-up point compared between experimental and control groups
time frame: 15 days after randomization
measure: 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
measure: Rate of all adverse events occurred during the study and compare their incidence between intervention and control groups
time frame: 15 days after randomization
arm group label: Intervention
arm group type: Experimental
description: 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).
arm group label: Control
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Magnesium
description: 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).
arm group label: Intervention
intervention type: Drug
intervention name: Placebo Oral Tablet
description: 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.
arm group label: Control
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Frédéric Limosin, M.D., Ph.D.
role: Principal Investigator
affiliation: Assistance Publique-Hôpitaux de Paris (AP-HP)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Substance Withdrawal Syndrome
sharing ipd: No