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

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• diagnosed with HIV

• Receive care at the Atlanta VA Healthcare System

• Age 18 or over

• Meet criteria for moderate to severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist

• Score >7 on 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.