Could a common heart pill curb alcohol cravings?
NCT ID NCT05807139
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 5 times
Summary
This early-phase study tests whether spironolactone, a drug currently used for high blood pressure and heart failure, can be safely used in people with alcohol use disorder. Twenty participants will each stay at a clinic four times, taking either the drug or a placebo for five days, then drinking alcohol in a controlled setting. Researchers will measure how the body processes the drug and alcohol, and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spironolactone
- What this could lead to
- If this early study shows that spironolactone is safe and reduces alcohol craving or consumption, it could point toward a new treatment option for alcohol use disorder.
- What could go wrong
- This is a very small Phase 1b safety and dosing study with only 20 participants. It is not designed to prove effectiveness, and the drug may not reduce drinking in real-world settings. Side effects like high potassium or kidney issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institute on Drug Abuse
RECRUITINGBaltimore, Maryland, 21224, United States
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