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Could a heart drug curb alcohol cravings in HIV patients?

NCT ID NCT06004830

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This small pilot study tested whether giving spironolactone, a drug normally used for heart conditions, could help people with HIV reduce their alcohol use. Twenty-one participants received the drug along with support from a pharmacist and psychiatrist. The study focused on whether this approach was practical and safe, and looked for early signs it might cut down drinking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spironolactone
What this could lead to
If this works, it could point toward a new way to help people with HIV reduce their drinking.
What could go wrong
This is a very small pilot study with only 21 people, no comparison group, and it's testing a drug not approved for this use. Results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * diagnosed with HIV * Receive care at the Atlanta VA Healthcare System * Age 18 or over * Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen * Have evidence of significant alcohol use: PEth \> 20ng/ml * Prescribed \>=5 medications * Have cell phone or reliable contact number * Can provide written informed consent Exclusion Criteria: * Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment * Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive * Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment * Untreated moderate to severe opioid use disorder * Residence out of state * Inability to read or understand English * History of serious hypersensitivity or adverse reaction to study medication * Taking potentially interactive medication(s): eplerenone, potassium supplementation, lithium, digoxin, cholestyramine, heparin and low-molecular weight heparin for spironolactone) * Hyperkalemia defined as serum potassium ≥ 5.0 mEq/L on the most recent laboratory test performed in the past 60 days prior to enrollment or Addison's disease or estimated glomerular filtration rate \<50 mL/min/1.73 m2 (for spironolactone) * Creatinine level of ≥1.5 mg/dl (for spironolactone) * Already prescribed the pilot medication at the time of study recruitment.

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Conditions

The condition(s) this trial relates to.

AIDS alcohol abuse HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder HIV

Contacts and locations

Locations

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.