Spironolactone in Alcohol Use Disorder (SAUD)

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Apr 10, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Spironolactone in Alcohol Use Disorder (SAUD)**

This clinical trial is exploring whether a medication called spironolactone, which is usually used to treat high blood pressure and heart problems, can help people with Alcohol Use Disorder (AUD). Researchers want to see how spironolactone works in the body and if there are any side effects when it’s taken by individuals who sometimes drink too much alcohol. This study is particularly important because there are currently only a few medications approved for treating AUD, and many people are looking for better options.

To participate in this trial, individuals must be at least 21 years old and diagnosed with AUD, meaning they have experienced at least two symptoms from a specific set of questions about alcohol use. Participants will stay at a clinic in Baltimore for four separate weeks, where they will take spironolactone or a placebo (a harmless capsule that looks the same but contains no medicine) twice a day for five days during each stay. They will not drink alcohol until the sixth day of each stay, when they will be monitored in a controlled environment. Throughout the study, participants will undergo various tests, including scans and blood work, to help researchers understand the effects of the medication. This trial is currently recruiting participants, and it provides a chance to contribute to potential new treatments for AUD.

Gender

ALL

Eligibility criteria

• * 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., the Mini- International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview 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 ability to understand and sign the consent for the NIDA screening protocol.
• • 6. Female participants must be postmenopausal for at least one year, surgically sterile, or practicing a highly effective method of birth control before entry and throughout the study and must have negative pregnancy tests at each stage. Examples of highly effective methods of birth control include abstinence, hormonal contraceptives (e.g., certain birth control pills, contraceptive patch, vaginal ring, 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 \< 60 mL/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) or designee 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), angiotensin converting enzyme inhibitor (ACEI), potassium supplementation, potassium containing salt 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 MR antagonists, 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 determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past 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 interfere with study participation and/or be unsafe for a participant.