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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05522751
Eligibility Criteria:
Inclusion Criteria:
1. Adults (all genders) 21 to 75 years old.
2. Severe primary Alcohol Use Disorder (AUD) (\>= 6 Diagnostic and Statistical Manual-5 AUD criteria) with or without other substance use disorders.
3. Participants are seeking treatment for their AUD (participants receiving medications or other therapy for AUD are eligible).
4. Participants have insight into their alcohol use disorder (score \>26 on the recognition subscale of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES V.8)).
5. Participant has advanced compensated alcohol-associated liver disease (ALD). Compensated is defined as asymptomatic per clinical evaluation (by hepatologist or internist). Advanced is defined as fibrosis stage \>= 3; if not previously diagnosed, fibrosis stage \>= 3 will be diagnosed with liver elastography using a liver stiffness cutoff \>=15kiloPascal
6. AUD is treatment refractory: unable to achieve sustained remission (\>12 months) over the past 5 years, despite treatment attempts, with at least one treatment attempt involving completed residential or outpatient treatment program with pharmacotherapy, behavioral therapy, or both.
7. Stated willingness to comply with all study procedures and availability for the duration of the study.
8. Social support system and stable living arrangement to provide assurances that the subject will adhere to study requirements: family or friends who live with or near the subject, and can provide collateral information, monitor the subject's behavior, support, and encourage the subject to participate in follow-up visits and evaluations. This is evaluated by a neuropsychologist.
9. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to DBS surgery and agreement to use such a method during study participation, and after study completion if they elect to keep the DBS system implanted and ON.
Exclusion Criteria:
1. Pregnancy or lactation.
2. Non-English speaking.
3. AUD treatment with another investigational drug or other intervention within 3 months.
4. History of primary psychosis or Bipolar I disorder per the psychiatric evaluation or Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 measure.
5. History of severe personality disorder that could interfere with study participation (e.g., antisocial personality disorder) per the psychiatric evaluation, neuropsychological evaluation, or Structured Clinical Interview for the Diagnostic and Statistical Manual-5 measure.
6. Intelligence quotient \<75 as measured by Wechesler Abbreviated Scale of Intelligence (evaluated by a neuropsychologist).
7. History of suicidal attempts in the past 5 years or current suicidal thoughts per psychiatric evaluation and Columbia-Suicide Severity Rating Scale (C-SSRS).
8. Decompensated ALD: clinically obvious ascites, hepatic encephalopathy, jaundice episodes, large esophageal varices with or without variceal bleeding, hepatorenal syndrome, per the clinical evaluation (by hepatologist or internist).
9. Coagulopathy: international normalized ratio (INR) \> 1.4, activated partial thromboplastin time (aPTT) \> 40 s, platelets \< 100,000.
10. Current clinically significant medical or neurologic disease that affects brain function (e.g., recent stroke, myocardial infarction, seizures not due to alcohol withdrawal).
11. Clinically significant abnormality on structural brain MRI scan.
12. Life expectancy less than 18 months per the clinical judgement during medical evaluation (e.g., no terminal cancers).
13. Any labeled DBS contraindication or inability to have brain MRI: certain pacemakers, metal in body, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery, infection, and coagulopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT05522751
Study Brief:
Protocol Section:
NCT05522751