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

Recruiting now · Phase 2

Conditions studied: Alcohol Use Disorder (AUD), HIV

In brief

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.

Key facts

Study ID

NCT07040592

Run by

Yale University

People needed

30

Starts

2026-01-15

Expected to finish

2027-06-30

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Atlanta VA Medical Center — Decatur, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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