Spironolactone in Alcohol Use Disorder (SAUD)
Alcohol Use Disorder
About this trial
This is an interventional other trial for Alcohol Use Disorder focused on measuring Alcohol Consumption, Alcohol Problems, Alcohol Use Disorder, SPIRONOLACTONE, Mineralocorticoid Receptor
Eligibility 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)) Self-reported drinking, according to alcohol TimeLine Follow Back (TLFB) at least five days with >= 4 drinks for females or >= 5 drinks for males AND on average more than 1 drink per day for females or more than 2 drinks per day for males during the 28-day period prior to screening 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 an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at each visit. Examples of birth control methods include (but are not limited to) oral contraceptives or Norplant , barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms, intrauterine devices, a partner with a vasectomy, or abstinence from intercourse. EXCLUSION CRITERIA: 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 < 60 mL/min/1.73 m^2, hemoglobin A1c (HbA1c) > 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 (LMWH), trimethoprim, lithium, digoxin, cholestyramine 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 past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening. 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
Sites / Locations
- National Institute on Drug AbuseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Placebo 1st visit
Placebo 2nd visit
Placebo 3rd visit
Placebo 4th visit
Visit 1: PlaceboVisit 2: 100 mg/day spironolactoneVisit 3: 200 mg/day spironolactoneVisit 4: 400 mg/day spironolactone
Visit 1: 100 mg/day spironolactoneVisit 2: PlaceboVisit 3: 200 mg/day spironolactoneVisit 4: 400 mg/day spironolactone
Visit 1: 100 mg/day spironolactoneVisit 2: 200 mg/day spironolactoneVisit 3: PlaceboVisit 4: 400 mg/day spironolactone
Visit 1: 100 mg/day spironolactoneVisit 2: 200 mg/day spironolactoneVisit 3: 400 mg/day spironolactoneVisit 4: Placebo