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New treatment option for Alcohol Use Disorder
Official title Spironolactone in Alcohol Use Disorder (SAUD)
ClinicalTrials.gov ID: NCT05807139
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- 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...
- 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...
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is \< 10
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Most recent blood tests: potassium \> 5.2 mmol/L; creatinine \>= 2 mg/dL; eGFR \ 6.5 %
- Clinically significant and/or symptomatic hyponatremia, hypomagnesemia, hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI)...
- 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)
See the full eligibility 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...
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Most recent blood tests: potassium \> 5.2 mmol/L; creatinine \>= 2 mg/dL; eGFR \ 6.5 %
- Clinically significant and/or symptomatic hyponatremia, hypomagnesemia, hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI) or designee judgment.
- 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)
- 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...
- Current use of MR antagonists
- Current use of FDA-approved pharmacotherapy for AUD, or seeking treatment for AUD
- Known history of prior hypersensitivity reaction to spironolactone or other MR antagonists, or any of the product components
- Known history of alcohol withdrawal seizure and delirium tremens.
- 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...
- Pregnancy, intention to become pregnant, or breastfeeding.
- Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.