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

Completed · Phase 2

Conditions studied: Alcohol Use Disorder, Hiv

In brief

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.

Key facts

Study ID

NCT06004830

Run by

Yale University

People needed

21

Starts

2023-11-06

Expected to finish

2026-01-20

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Atlanta VA Medical Center — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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