Semaglutide for Alcoholism in HIV/AIDS

(HARP Trial)

Overseen By June-Marie Weiss, MA, MEd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Diabetes medications

Disqualifiers: Pregnancy, Opioid use disorder, Diabetes, 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: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

E. Jennifer Edelman, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with HIV who also struggle with alcohol use disorder (AUD) and have experienced alcohol-related intimate partner violence. Participants should be interested in a new approach combining medication and behavioral intervention to reduce their alcohol consumption.

Inclusion Criteria

Receive care at the Atlanta VA Healthcare System

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

I have a cell phone or a reliable contact number.

Exclusion Criteria

Residence out of state

I am on medication for diabetes that might interact with other drugs.

BMI<23

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 12-week intervention including off-label use of semaglutide with medical management and a clinical pharmacist-delivered behavioral intervention

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study tests the off-label use of Semaglutide, a medication known for other treatments but not yet approved for AUD, along with medical management and support from clinical pharmacists to help patients reduce drinking.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive a prescription for semaglutide.

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+