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Alcohol Use DisorderPhase 2HARPNCT06004830

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1

A Phase 2 study testing Spironolactone in people with Alcohol Use Disorder and Hiv, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Alcohol Use Disorder, Hiv
What is being tested?
Spironolactone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
6 Nov 2023to 20 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

Read the detailed description

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered spironolactone in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

Being tested
Spironolactone
Medical subject headings
Alcoholism, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpironolactoneDrug

    All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support

Study groups in NCT06004830
Study groupRoleWhat they receive
SpironolactoneExperimentalParticipants will receive a prescription for spironolactone
Receives: Drug: Spironolactone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who complete enrollment and duration of sessions

    Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

    Measured: 12 weeks

  2. Number of sessions completed

    Number of sessions completed to assess acceptability of study

    Measured: 12 weeks

  3. Adherence to Medication

    Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

    Measured: 12 weeks

  4. Safety of study assessed by adverse events reporting

    Safety will be assessed by the percentage of study participants who report adverse events

    Measured: 12 weeks

Secondary outcomes (2)

  1. Efficacy of study - change in self-reported alcohol use

    Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.

    Measured: 12 weeks

  2. Efficacy of study - change in PEth (phosphatidylethanol) results

    PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start6 Nov 2023
  3. Primary completion20 Jan 2026
  4. Study completion20 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004830
Sponsor's protocol ID
2000033919_a
Other IDs
1P01AA029545-01
Acronym
HARP
Status last verified
Jun 2026
First submitted
16 Aug 2023
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spironolactone in people with Alcohol Use Disorder and Hiv, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who complete enrollment and duration of sessions (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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