Testing spironolactone for treating alcohol use disorder

Spironolactone in Alcohol Use Disorder (SAUD): A Double-Blind, Placebo-Controlled, Ascending Dose, Phase 1b Study

This study is testing if the medication spironolactone can help people with alcohol use disorder drink less by seeing how it works in their bodies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 99 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05807139 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of spironolactone, a medication typically used for high blood pressure, on individuals with alcohol use disorder (AUD). Participants will undergo four separate 7-day stays at a clinic in Baltimore, where they will take spironolactone capsules twice daily for five days. The study will assess how spironolactone interacts with alcohol in the body, focusing on its pharmacokinetics and pharmacodynamics, as well as monitoring safety and tolerability. The goal is to determine if spironolactone can be an effective treatment for reducing alcohol consumption in people with AUD.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older who have been diagnosed with alcohol use disorder.

Not a fit: Patients who do not have alcohol use disorder or those who are not able to comply with the study's requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for individuals struggling with alcohol use disorder.

How similar studies have performed: While spironolactone has not been tested for alcohol use disorder specifically, its effects on alcohol consumption in animal studies suggest potential for success in this novel approach.

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.

Where this trial is running

Baltimore, Maryland

• National Institute on Drug Abuse — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Lorenzo Leggio, M.D. — National Institute on Drug Abuse (NIDA)
• Study coordinator: Masoumeh Dejman

Conditions Alcohol Use Disorder; Alcohol Consumption; Alcohol Problems; SPIRONOLACTONE; Mineralocorticoid Receptor