Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: addiction, other_emerging
- Who it enrolls
- age 18 Years to 99 Years; excludes diabetes; no BMI minimum stated; conditions: Alcohol Use Disorder (AUD); HIV
- Interventions
- semaglutide
- Conditions
- Alcohol Use Disorder (AUD); HIV
- Phase and size
- Phase 2 · 30 participants
- Dates
- Start 2026-01-15
Primary completion 2027-06-30 - Sponsor
- Yale University (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Proportion of participants who complete enrollment and duration of sessions12 weeks
- Number of sessions completed12 weeks
- Adherence to Medication12 weeks
- Safety of study assessed by adverse event reporting12 weeks
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.