Spironolactone for Alcoholism in HIV Patients

(HARP Trial)

Overseen By June-Marie Weiss, MA, MEd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Eplerenone, Potassium, Lithium, others

Disqualifiers: Pregnancy, Opioid use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking certain medications that interact with spironolactone, such as eplerenone, potassium supplements, lithium, digoxin, cholestyramine, and heparin.

How does the drug spironolactone differ from other treatments for alcoholism in HIV patients?

Spironolactone is unique because it is a nonselective mineralocorticoid receptor antagonist that has shown promise in reducing alcohol consumption in both animal and human studies, making it a novel option for treating alcohol use disorder, especially in people living with HIV. ^{1 2 3 4 5}

Research Team

E. Jennifer Edelman, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

Has evidence of significant alcohol use: PEth > 20ng/ml

I have been diagnosed with HIV.

Receives care at the Atlanta VA Healthcare System

Exclusion Criteria

I do not have any severe health or mental conditions that would stop me from participating.

I am currently in a formal alcohol treatment program.

Has an inability to read or understand English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week intervention including off-label use of medication with medical management and a clinical pharmacist-delivered behavioral intervention to treat AUD.

12 weeks

Regular study visits for counseling and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Spironolactone Experimental Treatment 1 Intervention

Participants will receive a prescription for spironolactone

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Among individuals diagnosed with alcohol use disorder, only 1.0% of people living with HIV (PLWH) and 0.14% were retained on medications for alcohol use disorder (MAUD), indicating a significant treatment gap.

PLWH were less likely to initiate MAUD compared to uninfected individuals, with factors like older age and being black associated with lower odds of starting treatment, highlighting the need for targeted strategies to improve access and retention in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. Oldfield, BJ., McGinnis, KA., Edelman, EJ., et al.[2021]

In a randomized clinical trial involving 194 women living with HIV, daily oral naltrexone (50 mg) showed a greater reduction in alcohol consumption at 1 and 3 months compared to placebo, although the overall reduction in drinking at 4 and 7 months was similar between both groups.

Women who reduced or quit drinking had significantly better HIV viral suppression rates at 4 months (72% vs. 53%) and 7 months (74% vs. 54%), highlighting the importance of reducing unhealthy alcohol use for improving health outcomes in women living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in Drinking was Associated With Improved Clinical Outcomes in Women With HIV Infection and Unhealthy Alcohol Use: Results From a Randomized Clinical Trial of Oral Naltrexone Versus Placebo. Cook, RL., Zhou, Z., Miguez, MJ., et al.[2020]

The NOAH Study, involving 365 participants predominantly male and African American, aims to investigate the adverse health outcomes of alcohol use in people living with HIV, building on preclinical findings from rhesus macaque models.

Baseline results show that while 12.8% of participants had low CD4 counts and 73.6% had undetectable viral loads, these HIV status indicators did not vary with alcohol use, suggesting a complex relationship between alcohol consumption and HIV health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Orleans Alcohol Use in HIV Study: Launching a Translational Investigation of the Interaction of Alcohol Use with Biological and Socioenvironmental Risk Factors for Multimorbidity in People Living with HIV. Welsh, DA., Ferguson, T., Theall, KP., et al.[2021]

A pilot study involving 17 women living with HIV/AIDS showed that both naltrexone and placebo led to significant reductions in alcohol consumption, from an average of 39.2 drinks per week to 12.8 drinks per week over 4 months.

The study demonstrated that a pharmacologic intervention for reducing alcohol consumption is feasible and acceptable in this population, although recruitment challenges were noted that need to be addressed for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results. Cook, RL., Weber, KM., Mai, D., et al.[2022]

In both mouse and rat models, spironolactone significantly reduced alcohol consumption without affecting the intake of non-alcoholic sweet solutions or other behaviors, indicating its specific action on alcohol use.

In a human study, individuals taking spironolactone for at least 60 days reported a greater reduction in alcohol consumption, especially among those with higher baseline alcohol use, suggesting its potential as a novel treatment for alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spironolactone as a potential new pharmacotherapy for alcohol use disorder: convergent evidence from rodent and human studies. Farokhnia, M., Rentsch, CT., Chuong, V., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Reduction in Drinking was Associated With Improved Clinical Outcomes in Women With HIV Infection and Unhealthy Alcohol Use: Results From a Randomized Clinical Trial of Oral Naltrexone Versus Placebo. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The New Orleans Alcohol Use in HIV Study: Launching a Translational Investigation of the Interaction of Alcohol Use with Biological and Socioenvironmental Risk Factors for Multimorbidity in People Living with HIV. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Spironolactone as a potential new pharmacotherapy for alcohol use disorder: convergent evidence from rodent and human studies. [2023]