Spironolactone in Alcohol Use Disorder (SAUD)

• INCLUSION CRITERIA:

In order to be eligible to enroll in this study, an individual must meet all of the following criteria:

1. At least 21 years old

2. Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., theMini- International Neuropsychiatric Interview (MINI) or the Structured ClinicalInterview for DSM Disorders (SCID))

3. At least four days with >= 4 drinks for females or >= 5 drinks for males during the 28-day period prior to screening, according to alcohol TimeLine Follow Back (TLFB)

4. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar)score is < 10

5. Able to speak, read, write, and understand English as demonstrated by their abilityto understand and sign the consent for the NIDA screening protocol.

6. Female participants must be postmenopausal for at least one year, surgicallysterile, or practicing a highly effective method of birth control before entry andthroughout the study and must have negative pregnancy tests at each stage. Examplesof highly effective methods of birth control include abstinence, hormonalcontraceptives (e.g., certain birth control pills, contraceptive patch, vaginalring, or implants), intrauterine device (IUD), tubal ligation, or vasectomy.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Most recent blood tests: potassium > 5.2 mmol/L; creatinine >= 2 mg/dL; eGFR < 60mL/min/1.73 m^2, hemoglobin A1c (HbA1c) > 6.5 %

2. Clinically significant and/or symptomatic hyponatremia, hypomagnesemia,hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI) ordesignee judgment.

3. Known history of clinically significant orthostatic hypotension

4. Known history of hypoaldosteronism, hyperaldosteronism, Addison s disease

5. Diagnosis of NYHA class III-IV heart failure, or unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)

6. Current use of any diuretic, angiotensin receptor blocker (ARB), angiotensinconverting enzyme inhibitor (ACEI), potassium supplementation, potassium containingsalt substitute, heparin and low molecular weight heparin (LMWH), trimethoprim,lithium, digoxin, cholestyramine

7. Current use of MR antagonists

8. Current use of FDA-approved pharmacotherapy for AUD, or seeking treatment for AUD

9. Known history of prior hypersensitivity reaction to spironolactone or other MRantagonists, or any of the product components

10. Known history of alcohol withdrawal seizure and delirium tremens.

11. Physical and/or mental health conditions that are clinically unstable, as determinedby the study clinicians, including (but not limited to) major depressive disorder orgeneralized anxiety disorder unstable during the past three months or otherpsychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during thepast twelve months prior to screening.

12. Pregnancy, intention to become pregnant, or breastfeeding.

13. Any other reason or clinical condition that the Investigators judge would interferewith study participation and/or be unsafe for a participant.