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

Launched by YALE UNIVERSITY · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called semaglutide, which is already used for other health issues, can help reduce alcohol use in people who have both HIV and Alcohol Use Disorder (AUD). The study will also include medical support and counseling from a pharmacist to see if this combined approach is practical, acceptable, and helpful in lowering alcohol use. The goal is to find out if this treatment could work before testing it in a larger group.

To take part, individuals must be 18 or older, have HIV, and be receiving care at the Atlanta VA Healthcare System. They also need to have a certain level of alcohol use, verified by specific tests, and be taking five or more medications. Participants should be able to communicate by phone and give consent to join the study. People currently in formal alcohol treatment or with certain health conditions, like pregnancy or serious medical issues, will not be eligible. If selected, participants will receive the medication along with support from healthcare providers to help manage their alcohol use. This study is not yet recruiting, but it aims to explore a new way to support people living with HIV who struggle with alcohol use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.