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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 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.

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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

Conditions Studied

Alcohol Use Disorder

Interventions

  • OTHER Placebo
  • DRUG Spironolactone

Study Locations (1)

Maryland

  • National Institute on Drug Abuse - Baltimore

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-07-13
Est. Completion 2027-04-30
Phase Phase 1

Sponsor

National Institute on Drug Abuse (NIDA)

335 total trials

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What the Registry Record Tells You About NCT05807139

The ClinicalTrials.gov registry entry for NCT05807139 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.