Alcohol Withdrawal SyndromePhase 3MAGMANCT03033823
MAGnesium Adjunction in Alcohol Withdrawal Syndrome: a Multicenter Assessment (MAGMA)
A Phase 3 study testing Magnesium in people with Alcohol Withdrawal Syndrome, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Nov 2017to 23 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital Louis Mourier, AP-HP
Colombes, Île-de-France Region, 92700
Clinique des Platanes
Épinay-sur-Seine, Île-de-France Region, 93800
Hôpital Corentin Celton, AP-HP
Issy-les-Moulineaux, Île-de-France Region, 92130
Institut MGEN de la Verriere
Le Mesnil-Saint-Denis, Île-de-France Region, 78322
Institut MGEN la Verriere-service SSR addictologie
Le Mesnil-Saint-Denis, Île-de-France Region, 78322
Hôpital Emile ROUX
Limeil-Brévannes
Clinique des maladies mentales et de l'encéphale
Paris, Île-de-France Region, 75014
Hôpital Européen Georges Pompidou-Service de chirugie orthopédique, AP-HP
Paris, Île-de-France Region, 75015
Hôpital Européen Georges Pompidou-Service de médecine interne, AP-HP
Paris, Île-de-France Region, 75015
Hôpital européen Georges-Pompidou-Service hépato-gastroentérologie
Paris, Île-de-France Region, 75015
Centre Hospitalier des quatre villes
Sèvres, Île-de-France Region, 92310
About this study
Official title: Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome
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.
Read the detailed description
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.
- Conditions
- Alcohol Withdrawal Syndrome
- Being tested
- Magnesium, Placebo Oral Tablet
- Keywords
- Alcoholism, Delirium, Magnesium Deficiency
- Medical subject headings
- Alcoholism, Delirium, Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Placebo Oral TabletDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group absolute difference of the CIWA-Ar score (revised clinical institute withdrawal assessment for alcohol scale) change from baseline
Measured: 3 days after randomization
Secondary outcomes (10)
Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study
Measured: 15 days after randomization
The delay compared between experimental and control groups until having a total score of 0 at the CIWA-Ar
Measured: 15 days after randomization
The rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups
Measured: 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
Measured: 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
Measured: 3 days after randomization
The number of participants who left the hospital against medical advice during the study compared between intervention and control groups
Measured: 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
Measured: 15 days after randomization
Patient Satisfaction Questionnaire-18 scores at the last follow-up point compared between experimental and control groups
Measured: 15 days after randomization
Total plasmatic or serum magnesium concentration changes between baseline,3 days after baseline, and 7 days after baseline, compared between intervention and control groups
Measured: 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
Measured: 15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start16 Nov 2017
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Frédéric Limosin, M.D., Ph.D., Principal investigator, Assistance Publique-Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033823
- Sponsor's protocol ID
- P150939
- Other IDs
- 2016-002072-26, PHRC, 2016
- Acronym
- MAGMA
- Status last verified
- Dec 2021
- First submitted
- 3 Jan 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome
- ClinicalTrials.gov ID
- NCT03033823
- Acronym / sponsor ID
- MAGMA / P150939
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- Alcoholism, Delirium, Magnesium Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: MagnesiumUsual 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). |
| Control | Placebo comparator | Drug: Placebo Oral TabletUsual 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnesiumUsual 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 | Intervention |
| Placebo Oral TabletAlso: PlaceboUsual 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 | Control |
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
10 secondary outcomes
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 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
Rate of all adverse events occurred during the study and compare their incidence between intervention and control groups
Time frame: 15 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Alcohol Withdrawal Syndrome
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
Not yet recruiting
Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal
Cognitive Cycling, Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Limosin, M.D., Ph.D. principal investigator
Assistance Publique-Hôpitaux de Paris (AP-HP)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium in people with Alcohol Withdrawal Syndrome, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.