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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT06787235
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* AUD diagnosis according to Diagnostic and Statistical Manual (DSM)-5
* BMI \> 22 (because of potential modified KD-side effect of weight loss)
* Able to give informed consent as documented by signature
* Last alcohol drink intake within 72 hours before treatment initiation
Exclusion Criteria:
* Pregnant or lactating women,
* Inability or contraindications to undergo the investigated intervention (BMI\<18)
* Clinically significant concomitant diseases impairing reasonable decision making (e.g. psychosis, dementia)
* Inability to follow the procedures of the study, e.g. due to language problems, Previous enrolment in a clinical trial
* Patients undergoing opioid maintenance treatment
* Patients taking medications for drinking relapse prevention
* Patients with a blood hemoglobin A1C (HbA1C) \> 7%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06787235
Study Brief:
Protocol Section:
NCT06787235