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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05135767
Eligibility Criteria:
General Inclusion Criteria. To be eligible, the interested volunteer must:
1. Be at least 18 years of age.
2. Meet the Diagnostic and Statistical Manual-5 criteria for alcohol use disorder, indicated by meeting 2 or more symptom criteria.
3. If male, report 14 or more standard alcoholic drinks per week, or if female, report 7 or more standard alcoholic drinks per week at any point in the 90 days prior to enrollment.
4. Be able to speak and read English or Spanish in order to provide written informed consent and understand written and oral instructions in English or Spanish.
General Exclusion Criteria. Interested volunteers must not have any of the following:
1. Meet the Diagnostic and Statistical Manual-5 criteria for a current diagnosis of psychotic disorders.
2. Currently receiving specialized psychosocial treatment for an alcohol-use or drug problem.
3. If female, pregnant or nursing.
4. Be anyone who, in the opinion of the investigative team, could not currently be safely withdrawn from alcohol without medical detoxification.
5. A BMI of 40 or more, or 35 or more and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
6. Known medical conditions that, in the opinion of the investigative team, would confound results (e.g., uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, hepatocellular carcinoma or other active malignancies except skin cancer).
7. Patients who have received a liver transplant or are too ill to participate.
8. Pre-existing loss of kidney function with estimated glomerular filtration rate \< 30.
9. Any other condition that, in the opinion of the investigative team, would make the interested volunteer unsuitable for the study or unable to comply with the requirements.
Additional Inclusion Criteria for the ALD + AUD Arm.
To be eligible in the ALD+AUD group, the interested volunteer must be diagnosed with advanced alcohol-associated liver disease (i.e., either alcoholic hepatitis or alcoholic cirrhosis). ALD will be determined by chart review. Interested volunteers must have one of the following:
1. Positive liver biopsy, or
2. Fibroscan® score \> 12.5, or
3. Evidence of a nodular liver or portal hypertension on abdominal imaging, or
4. Presence of portal hypertensive complications such as hepatic encephalopathy, ascites, or varices, or
5. Fibrosis-4 index \>= 3.25, or
6. Aspartate transaminase-platelet ratio index \>= 1.0.
Additional Exclusion Criteria for the AUD-only Arm. To be eligible in the AUD-only group, the interested volunteer must not show the following diagnostic test results indicating advanced, alcoholic fibrosis \>=F3.
1. Fibrosis-4 index \>= 3.25\*, or
2. Aspartate transaminase-platelet ratio index \>= 1.0\*\*, or
3. Gamma-glutamyl transpeptidase-to-platelet ratio \>= 0.32.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05135767
Study Brief:
Protocol Section:
NCT05135767