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Semaglutide for Alcohol Use Disorder in Patients with HIV

This pilot study is looking at semaglutide, a medication, to help people with HIV who also have alcohol use disorder (AUD). All 30 participants will receive semaglutide along with support from a clinical pharmacist and an addiction psychiatrist. The study wants to see if this approach is practical, acceptable to patients, and if it shows early signs of reducing alcohol use. To join, you must be 18 or older, have HIV, receive care at the Atlanta VA Healthcare System, and meet criteria for mild, moderate, or severe AUD. You also need to show evidence of significant alcohol use through a PEth blood test and be on at least five other medications. The study will measure how many people complete the program, how many sessions they attend, and how well they take their medication over 12 weeks.

Study design
This is an open-label pilot study, meaning both you and the study team will know you are receiving semaglutide. It plans to include 30 participants.
What's involved
You will receive a prescription for semaglutide and meet with a clinical pharmacist and addiction psychiatrist. You will also have interviews, laboratory tests, and be asked to bring medication bottles to visits over 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 12 weeks, which is the duration of the intervention.

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NCT07040592

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Yale University
~30 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:semaglutide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who complete enrollment and duration of sessions
Measured over 12 weeks
+3 more outcomes measured

Conditions

Alcohol Use Disorder (AUD)
HIV

Explore related trials

Alcohol use disorderHIV Infection

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • E. Jennifer Edelman, MD, MHS · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

E. Jennifer Edelman, MD, MHS
[email protected]
203-737-7115
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

diagnosed with HIV
Receive care at the Atlanta VA Healthcare System
Age 18 or over
Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
Have evidence of significant alcohol use: PEth \> 20ng/ml
Prescribed \>=5 medications
Have cell phone or reliable contact number
Can provide written informed consent

Exclusion

Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)
Untreated moderate to severe opioid use disorder
Residence out of state
Inability to read or understand English
History of serious hypersensitivity or adverse reaction to study medication
Taking potentially interactive medication(s) for diabetes
BMI\<23
Diagnosis of type 1 Diabetes
Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease
Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema
Already prescribed the pilot medication at the time of study recruitment.

What this trial measures

  • Proportion of participants who complete enrollment and duration of sessions12 weeks

    Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

  • Number of sessions completed12 weeks

    Number of sessions completed to assess acceptability of study

  • Adherence to Medication12 weeks

    Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

  • Safety of study assessed by adverse event reporting12 weeks

    Safety will be assessed by the percentage of study participants who report adverse events.