Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT05216705
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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,
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05216705
Study Brief:
Protocol Section:
NCT05216705