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Alcohol WithdrawalSTEP-AWNCT05216705

Study of Exploratory Plasmatic Markers of Alcohol Withdrawal

An observational study of Alcohol Withdrawal, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research focuses on alcohol withdrawal in hospitals and its potential neurological consequences. Alcohol withdrawal is an event that induces physical symptoms, such as tremors, sweating, anxiety and requires medical support. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Withdrawal
How many people
28 participants
Where
1 siteFrance
Study dates
19 Apr 2023to 17 Apr 2024
Phase
Observational
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population of the study STEP-AW is the male and female patients, aged 18 to 65 years inclusive, admitted for inpatient alcohol withdrawal. In terms of the number of patients included, it is planned to include up to a maximum of 25 patients to obtain 18 patients with the three samples performed (i.e. 7 replacements maximum).

Who may be able to join

  • Admission for inpatient alcohol withdrawal (planned or unplanned)
  • Last alcohol consumption less than 24 hours before admission to hospital
  • Active alcohol use disorder (DSM 5 criteria)
  • Age 18 to 65 years
  • Affiliation to a social welfare system or beneficiary of such a system.

Who cannot join

  • Active use disorder of benzodiazepines, delta-9-tetrahydrocannabinol (THC), opioids, cocaine, amphetamines, new synthetic drug, gamma-hydroxybutyrate/gamma-butyrolactone, hallucinogens, assessed by interview
  • Use in the previous 30 days of THC, opioids, cocaine, amphetamines, a new synthetic product, gamma-hydroxybutyrate/gamma-butyrolactone, hallucinogenic substances, assessed by questioning or positive by urine test,
  • Patient on opioid maintenance therapy (methadone or buprenorphine)
  • Presence of decompensated cirrhosis (Child Pugh score B or C) on admission or liver insufficiency with a TP < 70%,
  • Presence of severe acute alcoholic hepatitis (Maddrey score ≥32) on admission,
  • Presence of chronic renal failure with a glomerular filtration rate of less than 60mL/minute/1.73m2 estimated by the Cockroft formula,
Show all 18Show fewer
  • Presence of acute renal failure,
  • Presence of another condition that may cause brain damage :
  • epileptic seizure, stroke, head trauma within the last three months,
  • previously diagnosed severe cognitive impairment
  • history or active infection with HIV, hepatitis C virus (HCV) or syphilis, known and noted in the medical record, collected in the history or noted in the systematic screening for sexually transmitted infections carried out for care,
  • Patient with a language barrier (unable to follow the protocol or respond to clinical assessments),
  • Hospitalization expected to be less than 15 days and not able to perform the protocol assay at D14,
  • Pregnant, parturient or breastfeeding women,
  • Person deprived of liberty by judicial or administrative decision,
  • Person hospitalised without consent and not subject to a legal protection measure,
  • Person subject to an exclusion period for other research,
  • Adult person subject to a legal protection measure, adult person unable to express his or her consent and not subject to a protection measure.

Trial locations and contacts

1 site in 1 country.

France1 site
  • GHU APHP Nord - Université de Paris, Site Lariboisière Fernand-Widal

    Paris, F-75010

Other trials in France

About this study

This research focuses on alcohol withdrawal in hospitals and its potential neurological consequences.

Alcohol withdrawal is an event that induces physical symptoms, such as tremors, sweating, anxiety and requires medical support. Sometimes alcohol withdrawal results in neurological complications, such as epileptic seizures, delirium tremens, Wernicke Encephalopathy, memory and cognitive disorders. Chronic alcohol consumption and lack of vitamin B1 also cause neurological damage. Magnetic resonance imaging of the brain can be used to assess severe forms, but gives little information about possible recovery and mild or transient forms.

Read more

Currently, there is no scientifically validated blood measurement to assess the intensity of these neurological complications, to predict their occurrence and recovery, or to distinguish between the consequences of chronic alcohol consumption, complications of alcohol withdrawal and vitamin B1 deficiency.

This is non-experimental, non-controlled observational research.

Four plasma biomarkers were selected to be evaluated in the field of alcoholology. t is the dosage of light neurofilaments (NFL), the Tau protein, the glial fibrillary acidic protein (GFAP) and the ubiquitin carboxyl terminal hydrolase L1 (UCHL-1). These biomarkers are studied, in particular in cerebrospinal fluid, in neurodegenerative diseases and in patients having experienced a cranial trauma. They were described in the literature as markers of cerebral suffering. NF-L would reflect the axon injury, Tau and UCHL-1 protein the neurons injury and GFAP the astrocytes injury. The Quanterix* assay technique (SIMOA technology) allows simultaneous assay of these 4 biomarkers, with a detection threshold 100 times lower than that of the ELISA technique. This allows plasma assays to be performed and is therefore more accessible and less risky for the patient than assays in cerebrospinal fluid.

The objective was to study the kinetics of these four biomarkers (NFL, Tau, GFAP, UCHL-1) during alcohol withdrawal, it was decided to measure these plasma biomarkers at three points during alcohol withdrawal : at the beginning of withdrawal (T1 = J1), after the time when withdrawal is most intense and complications such as Wernicke Encephalopathy or delirium tremens usually occur (T2 = J3-J4), and at the end of alcohol withdrawal management (T3 = J13-J15).

The choice of performing T1 the day after the patient's admission (D1) and not the day of the patient's admission (D0) was determined to allow a better homogeneity of the plasma assay and to respect the reflection period before signing the consent. Indeed, patients may have different levels of alcohol in their blood when they are admitted on the morning of D0. This induces a heterogeneous clinic and interferes with the interview and the delivery of an informed information. Moreover, the dosage thus carried out at D1 will be done fasting, on waking, while the patient will be non-alcoholic, under identical conditions for all patients.

In this exploratory study, the number of subjects needed is set at 18 subjects who have completed the research, i.e., having had three samples at D1 (T1), D3-J4 (T2) and D13-J15 (T3) without alcohol consumption until T3. Subjects leaving the study before this third test will be replaced up to a maximum of 7 replacements. With no previous study to our knowledge measuring these biomarkers in alcohol withdrawal, we cannot anticipate the variance. We therefore set the number of subjects to be included based on the capacity of a SIMOA assay kit for the four biomarkers NLF, Tau, GFAP, and UCHL-1. Anticipating, the risk of alcohol reconsumption, early discharge and lost to follow-up, it is planned to include 25 patients. Inclusions will end after the third follow-up visit (T3) of the 18th patient for whom we will have all three samples taken (complete data) or after T3 of the 25th patient included.

The risks for the patient are the occurrence of a complication during the procedures included in the protocol, i.e. for all patients, one or more haematomas at the points of venous sampling or the occurrence of a vagal malaise.

Keywords
biomarkers, alcohol use disorder, alcohol withdrawal, central nervous system, alcohol brain damage
Medical subject headings
Alcoholism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in NFL between T1 and T3

    The primary endpoint of the STEP-AW study will be the change in the measurement of the biomarkers at T1 (D1 of admission for alcohol withdrawal, i.e. at the start of withdrawal) and T3 (D13-D15, i.e. once alcohol withdrawal has been completed)

    Measured: day 1 to day 15

  2. Change in Tau protein between T1 and T3

    The primary endpoint of the STEP-AW study will be the change in the measurement of the biomarkers at T1 (D1 of admission for alcohol withdrawal, i.e. at the start of withdrawal) and T3 (D13-D15, i.e. once alcohol withdrawal has been completed)

    Measured: day 1 to day 15

  3. Change in GFAP between T1 and T3

    The primary endpoint of the STEP-AW study will be the change in the measurement of the biomarkers at T1 (D1 of admission for alcohol withdrawal, i.e. at the start of withdrawal) and T3 (D13-D15, i.e. once alcohol withdrawal has been completed)

    Measured: day 1 to day 15

  4. Change in UCHL1 between T1 and T3

    The primary endpoint of the STEP-AW study will be the change in the measurement of the biomarkers at T1 (D1 of admission for alcohol withdrawal, i.e. at the start of withdrawal) and T3 (D13-D15, i.e. once alcohol withdrawal has been completed)

    Measured: day 1 to day 15

Secondary outcomes (5)
  1. Change in biomarkers between T1 and T2

    Test of the difference in the measurement of these biomarkers at T1 (D1) and at T2 (D3-D4 of admission for alcohol withdrawal).

    Measured: day 1 to day 4

  2. Correlation of the change between T1 and T3 of the four biomarkers

    The correlation of the change between T1 and T3 in the levels of these four plasmatic biomarkers with each other (NFL, Tau, GFAP, UCHL-1)

    Measured: day 1 to day 15

  3. Correlation with the plasmatic glutamate

    Correlation of the change between T1 and T3 of the four biomarkers with the change of the plasmatic glutamate between T1 and T3

    Measured: day 1 to day 15

  4. Association with the intensity of alcohol withdrawal

    The association of the change between T1 and T3 in these biomarkers with the intensity of alcohol withdrawal at D1, expressed as the dose of benzodiazepine required to control withdrawal signs over the whole day of D1 (maximum daily dose during withdrawal).

    Measured: day 1 to day 15

  5. Association with neurological signs

    Association of the change between T1 and T3 of these biomarkers with signs of neurological severity of alcohol withdrawal at T1 expressed by the presence of clinical signs of the Wernicke Encephalopathy triad (ophthalmoplegia, ataxia, confusion).

    Measured: day 1 to day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start19 Apr 2023
  3. Primary completion17 Apr 2024
  4. Study completion17 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216705
Sponsor's protocol ID
C20-67
Acronym
STEP-AW
Status last verified
May 2024
First submitted
23 Nov 2021
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Clergue-Duval V, Questel F, Dereux A, Bouaziz-Amar E, Azuar J, Icick R, Rollet D, Bloch V, Jeanblanc J, Marie-Claire C, Laplanche JL, Bellivier F, Paquet C, Naassila M, Vorspan F. Longitudinal Study of Plasma NFL and GFAP as Biomarkers of Alcohol Withdrawal-Associated Brain Injury. Addict Biol. 2026 May;31(5):e70157. doi: 10.1111/adb.70157.

    PubMed 42070965

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Withdrawal, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 18 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Change in NFL between T1 and T3 (time frame: day 1 to day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216705, which also lists 1 linked publication.

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 23 Sep 2026.

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