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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether semaglutide, a drug often used for other conditions, can help reduce alcohol use in people with HIV who also struggle with alcohol addiction. The goal is to determine if this treatment is effective and easy to follow. Suitable participants have HIV, receive care at the Atlanta VA, and exhibit significant alcohol use without currently being in formal alcohol treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications for alcohol use disorder or certain diabetes medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide is generally well-tolerated. In one study, participants took semaglutide for alcohol use disorder, and most side effects were mild. Some experienced nausea or stomach issues, but these were not serious.

Another study found that semaglutide helped reduce alcohol and cigarette use, with no major safety concerns. While mild side effects may occur, semaglutide is usually safe.

The FDA has approved semaglutide for other conditions, such as diabetes, indicating its safety has been thoroughly evaluated. However, since individual responses vary, participants should monitor their well-being during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism in HIV/AIDS?

Semaglutide is unique because it offers a novel approach to treating alcoholism in individuals with HIV/AIDS by targeting the GLP-1 receptor, which is not a typical focus for current alcohol use disorder treatments. Most existing treatments for alcoholism, like naltrexone and acamprosate, work by modulating neurotransmitters related to reward and cravings. In contrast, semaglutide, originally used for diabetes and obesity, influences appetite and reward pathways in a different way, potentially reducing alcohol cravings and consumption. Researchers are excited about semaglutide because it could provide a dual benefit for those with HIV/AIDS, addressing both alcohol use and metabolic issues that are common in this population.

What evidence suggests that semaglutide might be an effective treatment for alcoholism in HIV/AIDS?

Research has shown that semaglutide, the treatment under study in this trial, may help reduce alcohol use. One study significantly lowered weekly alcohol cravings and some drinking habits. Another study found that semaglutide reduced binge drinking in mice. Early trial results suggest that people taking semaglutide drank less overall and experienced fewer heavy drinking episodes. While more research is needed, these findings suggest semaglutide could effectively treat alcohol use disorder. ^{1 6 7 8 9}

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2829811

Once-Weekly Semaglutide in Adults With Alcohol Use ... Over 9 weeks of treatment, semaglutide led to reductions in some but not all measures of weekly consumption, significantly reduced weekly alcohol craving ...

2. niaaa.nih.gov niaaa.nih.gov/news-events/spectrum/volume-16-issue-1-winter-2024/semaglutide-shows-promise-potential-alcohol-use-disorder-medication

Semaglutide Shows Promise as a Potential Alcohol Use ... In the current study, the researchers demonstrated that semaglutide reduced binge-like alcohol drinking in both male and female mice, and that ...

3. croiconference.org croiconference.org/wp-content/uploads/sites/2/posters/2025/1152-2025.pdf

The Impact of Semaglutide on Alcohol Use Among People ... HIV (PWH), although a recent small pilot trial among people without HIV with alcohol use disorder was suggestive of an effect on alcohol use. BACKGROUND.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07218354

A Randomized, Double-Blind, Placebo-Controlled Phase 3 ... ... Semaglutide in U.S. Veterans With Alcohol Use Disorder (CRAVE) ... Anti-HIV antibody positive test with uncontrolled or unstable treatment.

5. news.unchealthcare.org news.unchealthcare.org/2024/06/clinical-trial-on-semaglutide-shows-promise-for-treatment-of-alcohol-use-disorder-warrants-further-trials/

Clinical Trial on Semaglutide Shows Promise for Treatment ... Preliminary results from the trial indicate that those taking the medication experienced greater reductions in drinking quantity and heavy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221214

GLP-1 Receptor Agonists to Decrease Ethanol and CVD ... The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main ...

7. i-base.info i-base.info/htb/50245

Semaglutide reduces alcohol and cigarette use in a ... A final dose of 0.5 or 1.0 mg was given at week 9 to collect additional safety data. ... CROI 2024: HIV studies with semaglutide: significant ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11749217/

Does semaglutide reduce alcohol intake in Danish patients ... Glucagon-like peptide-1 (GLP-1) receptor agonists have shown promising effects in reducing alcohol consumption in preclinical experiments.

9. news.unchealthcare.org news.unchealthcare.org/2025/02/semaglutide-shows-promise-in-reducing-cravings-for-alcohol-heavy-drinking/

Semaglutide Shows Promise in Reducing Cravings for ... Randomized, placebo-controlled trial finds that low-dose semaglutide reduces amount of alcohol consumption, alcohol cravings, and heavy drinking days.