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NCT05807139 · ClinicalTrials.gov registry record · Phase 1
Spironolactone in Alcohol Use Disorder (SAUD)
A Phase 1 study of Alcohol Use Disorder, sponsored by National Institute on Drug Abuse (NIDA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05807139: Recruiting Phase 1 study of Alcohol Use Disorder, sponsored by National Institute on Drug Abuse (NIDA).
NCT05807139 is a Phase 1 study of Alcohol Use Disorder that is actively recruiting participants, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 20 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05807139, a Phase 1 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by National Institute on Drug Abuse (NIDA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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 remov
Primary Outcome
PK characteristics of spironolactone (e.g., total concentration, peak concentration, elimination half-life) before (day 5) and after (day 6) oral alcohol administration.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Spironolactone
Study Locations (1)
Maryland
- National Institute on Drug Abuse - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-13 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT05807139 shows while recruiting
NCT05807139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05807139 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05807139 about?
NCT05807139 is a clinical study titled "Spironolactone in Alcohol Use Disorder (SAUD)". 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 decrea...
What is the current status of trial NCT05807139?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-07-13. Estimated completion is 2027-04-30.
What conditions does trial NCT05807139 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT05807139?
The interventions under investigation include: Placebo (OTHER), Spironolactone (DRUG).
Who is sponsoring clinical trial NCT05807139?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05807139 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05807139's enrollment target sits among peer trials
20 165th of 184 higher than 15 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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