Off-label semaglutide for alcohol use disorder in people with HIV (pilot 3)
Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study
This pilot will test whether adding off-label semaglutide plus medical management and pharmacist-delivered counseling reduces drinking in people with HIV who have alcohol use disorder and take five or more medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT07040592 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with HIV who receive care at the Atlanta VA, meet DSM-5 criteria for mild to severe AUD, have PEth >20 ng/mL, are prescribed five or more medications, have reliable contact information, and can provide informed consent are the intended participants.
Not a fit: People who are pregnant or nursing, currently receiving formal AUD medication treatment, have unstable life‑threatening medical or psychiatric conditions, untreated moderate-to-severe opioid use disorder, or who live out of state are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce alcohol use and related harms in people with HIV and lower risks from medication interactions due to polypharmacy.
How similar studies have performed: GLP-1 receptor agonists such as semaglutide have shown promising signals in preclinical work and small human studies for reducing alcohol intake, but using semaglutide off-label for AUD in people with HIV is novel and not yet proven in larger trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Decatur, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.