Actively Recruiting
Spironolactone in Alcohol Use Disorder (SAUD)
Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3 medicines have been approved by Food and Drug Administration to treat AUD. Researchers want to find better treatments for AUD. Animal studies found that a medicine called spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is approved to treat high blood pressure, or heart failure in people. It is not approved to treat AUD. Objective: To test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order to understand how the body breaks down spironolactone and if there are any side effects in people who drink alcohol while taking this medicine. Eligibility: People aged 21 and older with AUD. Design: Participants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months. Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of the medicine. The placebo capsule looks just like the spironolactone capsule but contains no medicine. Participants will not know when they are taking the medicine or the placebo. Participants will not drink alcohol until day 6 of each clinic stay. Then they will be asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and their well-being will be measured. Participants will undergo other tests in the clinic: A DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle mass. Participants will lie on an open-top, padded table, then a small arm will scan the full length of their body. The radiation participants will get in this study is about the same as from one regular x-ray. Blood tests. Participants may feel some discomfort at the site of needle entry. Electrocardiogram. This test records the heart activity. Sensors are attached to the skin with stickers and removed after a few minutes. Urine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine. Questionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking.
CONDITIONS
Official Title
Spironolactone in Alcohol Use Disorder (SAUD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 21 years old
- Diagnosed with Alcohol Use Disorder with at least 2 symptoms on a validated diagnostic tool
- Had at least four days with 4 or more drinks for females or 5 or more drinks for males during the 28 days before screening
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score less than 10
- Able to speak, read, write, and understand English
- Female participants must be postmenopausal for at least one year, surgically sterile, or using a highly effective birth control method before and during the study with negative pregnancy tests at each stage
You will not qualify if you...
- Blood tests showing potassium higher than 5.2 mmol/L, creatinine 2 mg/dL or higher, estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2, or hemoglobin A1c above 6.5%
- Clinically significant and/or symptomatic low sodium, low magnesium, low calcium, or high uric acid levels
- History of clinically significant orthostatic hypotension
- History of hypoaldosteronism, hyperaldosteronism, or Addison's disease
- Diagnosis of NYHA class III-IV heart failure or unstable heart conditions including arrhythmias or significant ECG abnormalities
- Current use of diuretics, angiotensin receptor blockers, ACE inhibitors, potassium supplements or salt substitutes, heparin or low molecular weight heparin, trimethoprim, lithium, digoxin, or cholestyramine
- Current use of mineralocorticoid receptor antagonists
- Current use of FDA-approved treatments for Alcohol Use Disorder or seeking treatment for AUD
- Known allergy to spironolactone or related medications
- History of alcohol withdrawal seizures or delirium tremens
- Clinically unstable physical or mental health conditions including recent unstable major depression, anxiety, schizophrenia, or bipolar disorder
- Pregnancy, intention to become pregnant, or breastfeeding
- Any other condition judged by investigators to interfere with participation or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
M
Masoumeh Dejman
CONTACT
L
Lorenzo Leggio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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