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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT05048758
Eligibility Criteria:
Inclusion Criteria:
* Male and female
* Age between 18 and 65
* Normal or correctable eyesight
* Sufficient ability to communicate with the investigators, to answer questions in oral and written form
* "Fully Informed Consent"
* "Written Informed Consent"
* Individuals with alcohol use disorder according to DSM-5 or 'heavy drinking' (alcohol intake \> 40g/ more than 5 days (women) \& 60g/ more than 5 days (men) and varying levels of adverse childhood experiences
Exclusion Criteria:
* Withdrawal of the declaration of consent
* Exclusion criteria for an MRI scan (pregnancy, metal implants, etc.)
* Severe internal, neurological and psychiatric comorbidities
* Pharmacotherapy with psychoactive substances within the last 14 days (except treatment with SSRI/SNRIs for at least 28 days)
* Axis-I disorder according to ICD-10 and DSM 5 (except tobacco and alcohol use disorder, substance abuse with less than 2(11) criteria according to DSM-5, mild depressive episode, adaptation disorder and specific phobia within the last 12 months)
* Positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
* Withdrawal symptoms (CIWA-R \> 7)
* Intoxication at time of investigation (breathalyzer \> 0.3‰)
* Suicidal tendency or potential danger for others
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05048758
Study Brief:
Protocol Section:
NCT05048758