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Taking people in United StatesPhase 1

Spironolactone in Alcohol Use Disorder (SAUD)

Key facts

Who runs it
National Institute on Drug Abuse (NIDA)
Where
Baltimore, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 1
People taking part
20 people, planned
Started
13 Jul 2023
Expected to end
30 Apr 2027
Type of study
Interventional, 4 groups
Treatments tested
  • Placebo
  • Spironolactone
Record updated
9 November 2026

Who can take part

Age
21 years to 99 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who cannot take part

  • Known history of prior hypersensitivity reaction to spironolactone or other MR antagonists, or any of the product components
  • 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
  • Known history of clinically significant orthostatic hypotension
  • Known history of hypoaldosteronism, hyperaldosteronism, Addison s disease
  • Diagnosis of NYHA class III-IV heart failure, or unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)
  • Known history of alcohol withdrawal seizure and delirium tremens
  • Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
  • 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 %
  • 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
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Clinically significant and/or symptomatic hyponatremia, hypomagnesemia, hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI) or designee judgment
  • Current use of MR antagonists
  • Current use of FDA-approved pharmacotherapy for AUD, or seeking treatment for AUD
  • Pregnancy, intention to become pregnant, or breastfeeding

Other criteria

  • INCLUSION CRITERIA:; In order to be eligible to enroll in this study, an individual must meet all of the following criteria:
  • At least 21 years old
  • 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))
  • 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)
  • Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is < 10
  • Able to speak, read, write, and understand English as demonstrated by their ability to understand and sign the consent for the NIDA screening protocol
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 99 years old?

Where in United States

  • National Institute on Drug AbuseBaltimore, United StatesContact: Lorenzo Leggio, M.D.Taking people

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Placebo 1st visitTreatment being tested

    stage 1: Placebostage 2: 2x50 mg/day spironolactonestage 3: 2x100 mg/day spironolactonestage4: 2x200 mg/day spironolactone

    Treatment: Placebo and Spironolactone

  • Placebo 2nd visitTreatment being tested

    stage 1: 2x50 mg/day spironolactonestage 2: Placebostage3: 2x100 mg/day spironolactonestage 4: 2x200 mg/day spironolactone

    Treatment: Placebo and Spironolactone

  • Placebo 3rd visitTreatment being tested

    stage1: 2x50 mg/day spironolactonestage 2: 2x100 mg/day spironolactonestage 3: Placebostage4: 2x200 mg/day spironolactone

    Treatment: Placebo and Spironolactone

  • Placebo 4th visitTreatment being tested

    Stage1: 2x50 mg/day spironolactoneStage 2: 2x100 mg/day spironolactonestage 3: 2x200 mg/day spironolactonestage 4: Placebo

    Treatment: Placebo and Spironolactone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Spironolactone in Alcohol Use Disorder (SAUD): A Double-Blind, Placebo-Controlled, Ascending Dose, Phase 1b Study
Fit questions
Built from NCT05807139, who can take part
Record updated
9 November 2026