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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Atlanta VA Medical Center
RECRUITING
Decatur
Contact Information
Primary
E. Jennifer Edelman, MD, MHS
ejennifer.edelman@yale.edu
203-737-7115
Backup
June-Marie Weiss, MA, MEd
junemarie.weiss@yale.edu
203-737-3347
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Experimental: Spironolactone
Participants will receive a prescription for spironolactone
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This content was sourced from clinicaltrials.gov