Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2
Running, not enrolling · Phase 2
Conditions studied: Alcohol Use Disorder, Hiv, Tobacco Use Disorder
In brief
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.
Key facts
- Study ID
- NCT06006143
- Run by
- Yale University
- People needed
- 30
- Starts
- 2025-06-16
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosed with HIV
- Receive care at the Atlanta VA Healthcare System
- Are 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
- Currently smoking cigarettes
- Prescribed >=5 medications
- Have cell phone or reliable contact number
- Can provide written informed consent
You may not qualify if…
- 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) (e.g. nicotine replacement therapy for varenicline pilot study)
- Already prescribed the pilot medication at the time of study recruitment
Where it is running
- Atlanta VA Medical Center — Decatur, Georgia, United States
Full record on ClinicalTrials.gov
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