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NCT06004830CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
21 (actual)
First submitted
16 Aug 2023
Start date
6 Nov 2023
Primary completion date
20 Jan 2026
Lead sponsor
Yale University
Diseases
HIV
NCT number
NCT06004830

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 21
  • From 6 Nov 2023 to the primary completion date, 20 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Already prescribed the pilot medication at the time of study recruitment.

Other illness

  • Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
  • Untreated moderate to severe opioid use disorder
  • History of serious hypersensitivity or adverse reaction to study medication

Lab values

  • Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
  • 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)

Other

  • Residence out of state
  • Inability to read or understand English

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Atlanta VA Medical Center
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.