Spironolactone in Alcohol Use Disorder (SAUD)

This study is testing spironolactone, a medicine approved for high blood pressure and heart failure, to see how it works in people with Alcohol Use Disorder (AUD). Researchers want to understand how your body processes spironolactone when you also drink alcohol, and if there are any side effects. You would receive different doses of spironolactone (50 mg, 100 mg, and 200 mg per day) or a placebo (an inactive pill that looks the same). The main goal is to learn about how spironolactone and alcohol are handled by the body. This study is for people aged 21 and older who have Alcohol Use Disorder. The study is currently unclear on its status and plans to enroll 20 participants.

Study design
This is an interventional study with 20 participants, comparing spironolactone to a placebo. Participants will receive increasing doses of spironolactone or placebo in a blinded manner, meaning neither you nor the study staff will know which you are receiving.
What's involved
You will participate in three sessions, receiving increasing doses of spironolactone or placebo. During these sessions, researchers will measure how your body processes spironolactone and alcohol.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints measure drug levels before and after oral alcohol administration, and 12 hours after oral alcohol administration.

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NCT05807139

Spironolactone in Alcohol Use Disorder (SAUD)

Recruiting
PHASE1Ages 21–99Interventional
National Institute on Drug Abuse (NIDA)
~20 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:PlaceboSpironolactone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Describe steady-state PK of spironolactone in individuals with AUD, before and after oral alcohol administration.
Measured over Before and after oral alcohol administration.
+1 more outcome measured
Alcohol Use Disorder
1 sites across 1 states
Maryland1
  • Lorenzo Leggio, M.D. · PRINCIPAL_INVESTIGATOR · National Institute on Drug Abuse (NIDA)

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  • Describe steady-state PK of spironolactone in individuals with AUD, before and after oral alcohol administration.Before and after oral alcohol administration.

    PK characteristics of spironolactone (e.g., total concentration, peak concentration, elimination half-life) before (day 5) and after (day 6) oral alcohol administration.

  • Describe alcohol PK during concomitant spironolactone use12 hours after oral alcohol administration

    PK characteristics of alcohol (e.g., blood alcohol concentrations, time for elimination) during concomitant spironolactone treatment (0, 100, 200, and 400 mg/day)