HARP

RecruitingPhase 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

Lead sponsor

Yale University

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alcohol / substance use, HIV

Key I/E criterion

—

Primary endpoints

•Proportion of participants who complete enrollment and duration of sessions•Number of sessions completed•Adherence to Medication

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07040592

Org study ID2000033919_c

Secondary ID1P01AA029545-01

Timeline

Milestones

Study first posted2025-06-27actual

Study start2026-01-15actual

Last update posted2026-03-24actual

Primary completion2027-06-30estimated

Study completion2027-06-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance useHIV

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety of study assessed by adverse event reporting

Time frame:12 weeks

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Number of sessions completed

Time frame:12 weeks

event count, descriptive

Primary/protocol endpoint

Adherence to Medication

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Efficacy of study - change in self-reported alcohol use

Time frame:12 weeks

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Efficacy of study - change in PEth (phosphatidylethanol) results

Time frame:12 weeks

Alcohol consumption, change

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint

Proportion of participants who complete enrollment and duration of sessions

Time frame:12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.