NCT07040592 Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide
| NCT ID | NCT07040592 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-01-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
E. Jennifer Edelman, MD, MHS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07040592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07040592 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07040592 currently recruiting?
Yes, NCT07040592 is actively recruiting participants. Contact the research team at ejennifer.edelman@yale.edu for enrollment information.
Where is the NCT07040592 trial being conducted?
This trial is being conducted at Decatur, United States.
Who is sponsoring the NCT07040592 clinical trial?
NCT07040592 is sponsored by Yale University. The principal investigator is E. Jennifer Edelman, MD, MHS at Yale University. The trial plans to enroll 30 participants.