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:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT05275166
Eligibility Criteria:
Inclusion Criteria:
Patients (N=20):
* Subject with moderate to severe DSM-5 alcohol use disorder hospitalized for withdrawal as part of their routine care.
* Presence of spontaneous and/or in response to environmental stimuli (induced) self-described episodes of craving.
* Males with age ≥ 30 years and ≤ 60 years;
* Normal or corrected-to-normal visual acuity (declarative);
* Right-handed;
Healthy control volunteers (N=40):
* Men with age ≥ 30 years and ≤ 60 years;
* Normal or corrected-to-normal visual acuity;
* Right-handed;
* Smoker (current user, N=20) or Nonsmoker (never smoked, N=20);
* Alcohol consumption below the low-risk drinking threshold (\<10 standard drinks per week)
Exclusion Criteria:
For all subjects:
* Alcohol use in the 24 hours prior to the experiment;
* Consumption of psychoactive substances other than tobacco and alcohol (positive urine test).
* Presence of a contraindication related to the MRI technique
* Being under legal protection, and/or deprived of freedom;
* Not mastering the French language (written and oral);
* Inability to understand the information given on the study and/or to carry out the experimental task.
For patients:
* Presence of cognitive impairment (MoCA score \< 25)
* Absence of spontaneous or induced craving episodes
* Decompensated cirrhosis: ascites and/or encephalopathy and/or jaundice and/or recent hemorrhage
For healthy control volunteers:
* Significant medical or surgical history related to the central nervous system;
* Current use (\< 30 days) of drugs affecting the central nervous system belonging to the class of antidepressants, sleeping pills and/or anxiolytics.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT05275166
Study Brief:
Protocol Section:
NCT05275166