200 Participants NeededMy employer runs this trial

Semaglutide for Alcoholism in HIV

(GL1DER HIV RCT Trial)

HA
GW
RJ
Overseen ByRachel Jones, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanderbilt University Medical Center
Must be taking: ART regimen
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semaglutide, a medication typically used for diabetes and weight management, can help reduce alcohol consumption in people living with HIV. The researchers aim to determine if semaglutide also decreases cigarette smoking and lowers heart disease risk in this group. Participants will receive either semaglutide or a placebo to compare effects. This trial suits individuals with HIV who drink alcohol regularly and are currently on HIV medications. Participants must visit the clinic for checkups and tests while taking the medication for three months. 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 must not be taking GLP-1 RA medications in the past 3 months. 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 earlier studies, participants reported fewer days of heavy drinking and a reduced desire to drink alcohol when taking semaglutide compared to a placebo. This suggests that the drug can work effectively without causing major side effects. Another study found that semaglutide also helped reduce alcohol and cigarette use among participants. These results support the safety of semaglutide, especially since it is already approved for other uses. However, like any medication, it may cause some side effects, so discussing any concerns with a healthcare provider is important.12345

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

Semaglutide is unique because it targets alcoholism in individuals with HIV through a novel mechanism of action. Unlike traditional treatments for alcoholism, which often focus on behavioral therapies and medications like naltrexone or disulfiram, semaglutide is primarily known as a diabetes medication that impacts the GLP-1 receptor. This receptor is involved in regulating appetite and reward pathways, which could help reduce alcohol cravings and consumption. Researchers are excited about semaglutide because it offers a new approach by leveraging its effects on metabolism and cravings, potentially providing a dual benefit for people with HIV who experience alcohol use disorder.

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

Research has shown that semaglutide can help people reduce alcohol consumption. In some studies, participants taking semaglutide drank fewer alcoholic beverages each week compared to those taking a placebo, a pill with no active medicine. Semaglutide also reduced their cravings for alcohol. This trial will compare semaglutide with a placebo to evaluate its effectiveness in reducing alcohol consumption in individuals with HIV. Additionally, some studies found that semaglutide helped smokers cut down on cigarettes. Researchers are studying this drug for its potential to help people drink and smoke less, which could also lower health risks.12345

Who Is on the Research Team?

HA

Hilary A Tindle, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18-89) living with HIV who drink alcohol, are patients at Vanderbilt Comprehensive Care Clinic, have a BMI of 23 or higher, stable housing and contact info, good immune function (CD4 ≥ 300), on stable HIV meds, and can complete study visits. People with certain health conditions like diabetes or thyroid cancer can't join.

Inclusion Criteria

Self-report of consuming alcohol in past 90 days
Affiliated with Vanderbilt Comprehensive Care Clinic
BMI ≥ 23 (calculated at screening)
See 7 more

Exclusion Criteria

I have a family history of multiple endocrine neoplasia type 2.
Known allergy to semaglutide
I have had pancreatitis in the past.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take semaglutide or placebo for 3 months and visit the research clinic 3 times for checkups and tests, providing blood, stool, and saliva samples

3 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of systemic inflammation and cardiovascular risk

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study tests if semaglutide (Rybelsus®) helps reduce drinking and smoking in people with HIV compared to a placebo. Participants take the drug or placebo for 3 months while attending clinic visits and providing samples for testing.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Norton Healthcare

Collaborator

Trials
17
Recruited
2,900+

University of Louisville

Collaborator

Trials
353
Recruited
76,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39937469/

Once-Weekly Semaglutide in Adults With Alcohol Use Disorder

These findings provide initial prospective evidence that low-dose semaglutide can reduce craving and some drinking outcomes.

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 ...

Once-weekly semaglutide versus placebo in patients with ...

4 mg once-weekly reduces alcohol consumption in treatment-seeking patients with alcohol use disorder and comorbid obesity (BMI ≥30 kg/m2).

The Impact of Semaglutide on Alcohol Use Among People ...

We examined change in alcohol use with linear mixed models. (LMMs) of AUDIT-C scores prior to and after initiating semaglutide adjusted for age, sex, ...

Semaglutide reduces alcohol and cigarette use in a ...

Weekly semaglutide significantly reduced some criteria for alcohol intake. Reduced use of cigarettes was also reported among smokers in the study.