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HARP: Off-Label Spironolactone for AUD in HIV Patients
NCT06004830Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2023
- Primary completion
- Jan 2026
- Countries
- 1
- Sponsor
- Yale University
- Modality
- Small Molecules
- Drugs
- spironolactone
- Conditions
- alcohol use disorder (AUD)
01
Overview
Phase 2, open-label, single-arm trial of spironolactone in alcohol use disorder (AUD), sponsored by Yale University. Primary endpoints: Proportion of participants who complete enrollment and duration of sessions at 12 weeks, Number of sessions completed at 12 weeks and 2 more. Started Nov 2023; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Spironolactone
Participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support
03
Who it enrols
Adults with HIV and mild to severe alcohol use disorder, prescribed >=5 medications, excluding those pregnant, with unstable psychiatric conditions, or taking interacting medications.
04
Endpoints
Primary
Proportion of participants who complete enrollment and duration of sessions
Number of sessions completed
Adherence to Medication
Safety of study assessed by adverse events reporting
Secondary
Change in self-reported alcohol use
Change in PEth (phosphatidylethanol) results
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