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Spironolactone for Alcoholism in HIV Patients (HARP Trial)

N/A

Recruiting

Led By E. Jennifer Edelman, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

HARP Trial Summary

This trial tests if medication+behavioral intervention can reduce alcohol use in HIV+ people with AUD.

Who is the study for?

This trial is for adults over 18 with HIV and moderate to severe alcohol use disorder, who are patients at the Atlanta VA Healthcare System. They must have significant alcohol use indicated by specific tests, be on multiple medications, and able to give informed consent.Check my eligibility

What is being tested?

The study is testing Spironolactone as an off-label treatment for reducing alcohol consumption in individuals with HIV and AUD. It includes medical management and a behavioral intervention delivered by a clinical pharmacist.See study design

What are the potential side effects?

While not specified here, Spironolactone can typically cause side effects like dehydration, electrolyte imbalances, low blood pressure, dizziness, or kidney issues.

HARP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to Medication

Number of sessions completed

Proportion of participants who complete enrollment and duration of sessions

+1 more

Secondary outcome measures

Efficacy of study - change in PEth (phosphatidylethanol) results

Efficacy of study - change in self-reported alcohol use

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089

Hypotension

Diabetes related

Hyperkalemia

Infection

Chest pain/discomfort

Breast tenderness/Gynecomastia

Surgical

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

HARP Trial Design

1Treatment groups

Experimental Treatment

Group I: SpironolactoneExperimental Treatment1 Intervention

Participants will receive a prescription for spironolactone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spironolactone

2005

Completed Phase 4

~7340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,415 Total Patients Enrolled

424 Trials studying Alcoholism

985,838 Patients Enrolled for Alcoholism

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,531 Total Patients Enrolled

84 Trials studying Alcoholism

10,349 Patients Enrolled for Alcoholism

E. Jennifer Edelman, MD, MHSPrincipal InvestigatorYale School of Medicine

3 Previous Clinical Trials

876 Total Patients Enrolled

1 Trials studying Alcoholism

30 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are currently engaged in this experiment?

"Affirmative, clinicaltrials.gov data implies that patient recruitment is active for this study which was initially published on November 6th of 2023. Recent edits were made to the trial's page on November 7th, and currently 30 participants are required from a single medical centre."

Answered by AI

Is enrollment to this experiment taking place at the moment?

"Affirmative. The clinical trial is available on the website, having been first posted on November 6th 2023 and last updated on November 7th 2023. There are 30 positions to be filled at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004830.