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
Yale University
30 participants
Nov 6, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria11
- 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.
Interventions
All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06004830