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Not recruiting
Phase 2

Off-Label Medications

Sponsor:

Yale University

Code:

NCT06004830

Conditions

Alcohol Use Disorder

Hiv

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spironolactone

Study Details

Brief 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 among individuals with HIV and AUD.

Conditions

Alcohol Use Disorder

Hiv

Study ID

NCT06004830

Start date

Nov 6, 2023

Status verified date

Jan, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spironolactone

Participants will receive a prescription for spironolactone

Interventions

Spironolactone

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

Primary outcome measure

  • Proportion of participants who complete enrollment and duration of sessions [ Time Frame: 12 weeks ]
  • Number of sessions completed [ Time Frame: 12 weeks ]
  • Adherence to Medication [ Time Frame: 12 weeks ]
  • Safety of study assessed by adverse events reporting [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

E. Jennifer Edelman, MD, MHS

203-737-7115ejennifer.edelman@yale.edu

June-Marie Weiss, MA, MEd

203-737-3347junemarie.weiss@yale.edu

Locations

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Julie Costello

404-321-6111julie.costello2@va.gov

Principal Investigator:

Vincent Marconi, MD

More Information

Sponsor

Yale University

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-13.