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

Yale University

Status and phase

Enrolling

Phase 2

Conditions

Hiv

Alcohol Use Disorder

Treatments

Drug: Spironolactone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06004830

2000033919_a

1P01AA029545-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered spironolactone in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.