Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05807139 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorPrimary completion date: Aug 31, 2025 to Dec 31, 2025Completion date: Sep 7, 2025 to Apr 30, 2026v60Show 1 more changeShow less
Completion date: Sep 7, 2025 to Apr 30, 2026
MinorRe-verified, no change to tracked fieldsv59
NotablePrimary completion date: Aug 31, 2024 to Aug 31, 2025Completion date: Sep 7, 2024 to Sep 7, 2025v58Show 1 more changeShow less
Completion date: Sep 7, 2024 to Sep 7, 2025
Minor5 versionsRe-verified since Jun 13, 2024, no change to tracked fieldsv53-v57
MinorStudy Status, Eligibilityv52
MinorRe-verified, no change to tracked fieldsv51
MinorStart date changed from estimate of Feb 12, 2024 to Jul 13, 2023v50
MinorStart date: Feb 11, 2024 to Feb 12, 2024v49
MinorStart date: Feb 7, 2024 to Feb 11, 2024v48
MinorStart date: Feb 6, 2024 to Feb 7, 2024v47
MinorStart date: Feb 5, 2024 to Feb 6, 2024v46
MinorStart date: Feb 4, 2024 to Feb 5, 2024v45
MinorStart date: Feb 1, 2024 to Feb 4, 2024v44
MinorStart date: Jan 31, 2024 to Feb 1, 2024v43
MinorStart date: Jan 30, 2024 to Jan 31, 2024v42
MinorStart date: Jan 29, 2024 to Jan 30, 2024v41
MinorStart date: Jan 28, 2024 to Jan 29, 2024v40
MinorStart date: Jan 25, 2024 to Jan 28, 2024v39
MinorStart date: Jan 24, 2024 to Jan 25, 2024v38
MinorStart date: Jan 23, 2024 to Jan 24, 2024v37
MinorStart date: Jan 19, 2024 to Jan 23, 2024v36
MinorStart date: Jan 18, 2024 to Jan 19, 2024v35
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 removed after a few minutes.
Urine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine.
Questionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking.