Off-label semaglutide for alcohol use disorder in people with HIV (pilot 3)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label pilot delivers a 12-week intervention of off-label semaglutide combined with medical management and a clinical pharmacist–delivered behavioral program for people with HIV and alcohol use disorder. Participants receive counseling that uses brief feedback, advice, and motivational enhancement, and adherence is monitored by medication bottle checks. Assessments include AUDIT-C, the Alcohol Symptom Checklist, readiness-to-change measures, interviews, laboratory testing including PEth, and safety monitoring. The trial focuses on feasibility, acceptability, safety, and preliminary signals of reduced alcohol consumption.

Why it matters

Who can join: the full rules

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.

Where it's running

• Atlanta VA Medical Center
  Decatur, Georgia, United States Recruiting

Study contacts

• Principal investigator: E. Jennifer Edelman, MD, MHS — Yale University
• Study coordinator: E. Jennifer Edelman, MD, MHS
• Email: ejennifer.edelman@yale.edu
• Phone: 203-737-7115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.