NCT07040592RecruitingPhase 2
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide
Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 15 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT07040592
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 15 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Already prescribed the pilot medication at the time of study recruitment.
Other illness
- Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
- Untreated moderate to severe opioid use disorder
- History of serious hypersensitivity or adverse reaction to study medication
- Taking potentially interactive medication(s) for diabetes
- 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
Lab values
- Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
Other
- Residence out of state
- Inability to read or understand English
- BMI\<23
- Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta VA Medical Center Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.